| Title: | FDA New and End-dated CDRH Product Codes |
|---|---|
| Date: | 2018-09-04 |
| To: | abi,acee,acep,air,newace,ocean,partner,rail,truck |
| Links: | previous, original, next |
The Food and Drug Administration has created new product codes, which will be available in 60 days on November 5, 2018. The Food and Drug Administration is also end-dating product codes, effective in 60 days November 5, 2018. The new and end-dated codes are described below.
End-Dated Code/Description
74D--WM/Apparatus, Suction, Patient Care
New Code/Description
73D--WM / Apparatus, Suction, Patient Care
End-Dated Code/Description
84G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted
New Code/Description
73G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted
End-Dated Code/Description
74P--GJ / Oximeter, wellness
New Code/Description
73P--GJ / Oximeter, wellness
End-Dated Code/Description
82J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin
New Code/Description
75J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin
End-Dated Code/Description
91P--HV / Continuous glucose monitor retrospective data analysis software
New Code/Description
75P--HV / Continuous glucose monitor retrospective data analysis software
End-Dated Code/Description
77O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea
New Code/Description
76O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea
End-Dated Code/Description
84G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
New Code/Description
78G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
End-Dated Code/Description
85H--IR / Perineometer
New Code/Description
78H--IR / Perineometer
End-Dated Code/Description
74M--NW / Analyzer, Body Composition
New Code/Description
78M--NW / Analyzer, Body Composition
End-Dated Code/Description
85O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female
New Code/Description
78O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female
End-Dated Code/Description
80O--ZW / Ingestible event marker
New Code/Description
78O--ZW / Ingestible event marker
End-Dated Code/Description
85P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi
New Code/Description
78P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi
End-Dated Code/Description
85P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision
New Code/Description
78P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision
End-Dated Code/Description
74P--UH / Analyzer, body composition, exempt
New Code/Description
78P--UH / Analyzer, body composition, exempt
End-Dated Code/Description
85P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
New Code/Description
78P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
End-Dated Code/Description
78E--XM / Truss, Umbilical
New Code/Description
79E--XM / Truss, Umbilical
End-Dated Code/Description
78E--YN / Tray, Irrigation, Sterile
New Code/Description
79E--YN / Tray, Irrigation, Sterile
End-Dated Code/Description
78F--BQ / Trocar, Gastro-Urology
New Code/Description
79F--BQ / Trocar, Gastro-Urology
End-Dated Code/Description
78F--DP / Apparatus, Pneumoperitoneum, Automatic
New Code/Description
79F--DP / Apparatus, Pneumoperitoneum, Automatic
End-Dated Code/Description
78F--SH / Tray, surgical, needle
New Code/Description
79F--SH / Tray, surgical, needle
End-Dated Code/Description
78G--CG / Peritoneoscope
New Code/Description
79G--CG / Peritoneoscope
End-Dated Code/Description
78G--CH / Mediastinoscope
New Code/Description
79G--CH / Mediastinoscope
End-Dated Code/Description
78G--CI / Laryngoscope
New Code/Description
79G--CI / Laryngoscope
End-Dated Code/Description
74M--VR / Device, Anastomotic, Microvascular
New Code/Description
79M--VR / Device, Anastomotic, Microvascular
End-Dated Code/Description
89N--ZF / Massager, cosmetic, static electricity-emitting
New Code/Description
79N--ZF / Massager, cosmetic, static electricity-emitting
End-Dated Code/Description
84N--ZY / Light, lymphadema reduction, low energy
New Code/Description
79N--ZY / Light, lymphadema reduction, low energy
End-Dated Code/Description
84O--NA / Stereotaxic instrument
New Code/Description
79O--NA / Stereotaxic instrument
End-Dated Code/Description
80P--BZ / Surgical sponge visual scale
New Code/Description
79P--BZ / Surgical sponge visual scale
End-Dated Code/Description
78P--HU / Intra-abdominal pressure monitoring device
New Code/Description
79P--HU / Intra-abdominal pressure monitoring device
End-Dated Code/Description
73C--AH / Filter, Bacterial, Breathing-Circuit
New Code/Description
80C--AH / Filter, Bacterial, Breathing-Circuit
End-Dated Code/Description
74D--QF / Actuator, Syringe, Injector Type
New Code/Description
80D--QF / Actuator, Syringe, Injector Type
End-Dated Code/Description
74D--QI / Pump, Withdrawal/Infusion
New Code/Description
80D--QI / Pump, Withdrawal/Infusion
End-Dated Code/Description
79E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
New Code/Description80E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
End-Dated Code/Description
79E--YY / Drape, Urological, Disposable
New Code/Description
80E--YY / Drape, Urological, Disposable
End-Dated Code/Description
79F--IJ / System, Dialysate Delivery, Recirculating, Single Pass
New Code/Description
80F--IJ / System, Dialysate Delivery, Recirculating, Single Pass
End-Dated Code/Description
79F--RT / Unit, Isolation, Surgical
New Code/Description
80F--RT / Unit, Isolation, Surgical
End-Dated Code/Description
79F--XO / Suit, Surgical
New Code/Description
80F--XO / Suit, Surgical
End-Dated Code/Description
79F--XP / Cover, Shoe, Operating-Room
New Code/Description
80F--XP / Cover, Shoe, Operating-Room
End-Dated Code/Description
79F--XX / Mask, Surgical
New Code/Description
80F--XX / Mask, Surgical
End-Dated Code/Description
79F--XY / Hood, Surgical
New Code/Description
80F--XY / Hood, Surgical
End-Dated Code/Description
79F--XZ / Helmet, Surgical
New Code/Description
80F--XZ / Helmet, Surgical
End-Dated Code/Description
79F--YA / Gown, Surgical
New Code/Description
80F--YA / Gown, Surgical
End-Dated Code/Description
79F--YB / Gown, Patient
New Code/Description
80F--YB / Gown, Patient
End-Dated Code/Description
79F--YC / Gown, Isolation, Surgical
New Code/Description
80F--YC / Gown, Isolation, Surgical
End-Dated Code/Description
79F--YD / Apparatus, Exhaust, Surgical
New Code/Description
80F--YD / Apparatus, Exhaust, Surgical
End-Dated Code/Description
79F--YH / Splint, Extremity, Noninflatable, External
New Code/Description
80F--YH / Splint, Extremity, Noninflatable, External
End-Dated Code/Description
79H--MT / Drape, Patient, Ophthalmic
New Code/Description
80H--MT / Drape, Patient, Ophthalmic
End-Dated Code/Description
79H--MW / Drape, Microscope, Ophthalmic
New Code/Description
80H--MW / Drape, Microscope, Ophthalmic
End-Dated Code/Description
89I--QG / Adaptor, Holder, Syringe
New Code/Description
80--QG / Adaptor, Holder, Syringe
End-Dated Code/Description
79K--GO / Surgeon's Gloves
New Code/Description
80K--GO / Surgeon's Gloves
End-Dated Code/Description
79K--GQ / Cream, Gloving, Surgeon's
New Code/Description
80K--GQ / Cream, Gloving, Surgeon's
End-Dated Code/Description
79K--GT / Drape, Adhesive, Aerosol
New Code/Description
80K--GT / Drape, Adhesive, Aerosol
End-Dated Code/Description
79K--KX / Drape, Surgical
New Code/Description
80K--KX / Drape, Surgical
End-Dated Code/Description
79K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
New Code/Description
80K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
End-Dated Code/Description
79L--YU / Accessory, Surgical Apparel
New Code/Description
80L--YU / Accessory, Surgical Apparel
End-Dated Code/Description
79M--AC / Decontamination kit
New Code/Description
80M--AC / Decontamination kit
End-Dated Code/Description
79N--DC / Calculator, Drug Dose
New Code/Description
80N--DC / Calculator, Drug Dose
End-Dated Code/Description
89N--XB / Dispenser, solid medication
New Code/Description
80N--XB / Dispenser, solid medication
End-Dated Code/Description
74O--FM / Phlebotomy blood collection kit
New Code/Description
80O--FM / Phlebotomy blood collection kit
End-Dated Code/Description
89O--JL / insulin vial protector/holder
New Code/Description
80O--JL / insulin vial protector/holder
End-Dated Code/Description
79O--PA / Powder-free synthetic/non-latex surgeon's gloves
New Code/Description
80O--PA / Powder-free synthetic/non-latex surgeon's gloves
End-Dated Code/Description
79O--VR / Kit, first aid, talking
New Code/Description
80O--VR / Kit, first aid, talking
End-Dated Code/Description
82D--BT / Factor Xiii A, S, Antigen, Antiserum, Control
New Code/Description
81D--BT / Factor Xiii A, S, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control
New Code/Description
81D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DF / Prothrombin, Antigen, Antiserum, Control
New Code/Description
81D--DF / Prothrombin, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control
New Code/Description
81D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DX / Plasminogen, Antigen, Antiserum, Control
New Code/Description
81D--DX / Plasminogen, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GB / Seminal Fluid, Antigen, Antiserum, Control
New Code/Description
81D--GB / Seminal Fluid, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control
New Code/Description
81D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GR / Whole Human Serum, Antigen, Antiserum, Control
New Code/Description
81D--GR / Whole Human Serum, Antigen, Antiserum, Control
End-Dated Code/Description
88G--JH / Stain, Reticulocyte
New Code/Description
81G--JH / Stain, Reticulocyte
End-Dated Code/Description
88G--JJ / Stains, Heinz Body
New Code/Description
81G--JJ / Stains, Heinz Body
End-Dated Code/Description
88G--JL / Romanowsky Stains
New Code/Description
81G--JL / Romanowsky Stains
End-Dated Code/Description
88I--AZ / Heparin
New Code/Description
81I--AZ / Heparin
End-Dated Code/Description
88I--FO / Solution, Newcomer's
New Code/Description
81I--FO / Solution, Newcomer's
End-Dated Code/Description
88I--FS / Solution, Helly
New Code/Description
81I--FS / Solution, Helly
End-Dated Code/Description
88I--GK / Solution, Clarke's
New Code/Description
81I--GK / Solution, Clarke's
End-Dated Code/Description
88I--JZ / Oil, Clearing
New Code/Description
81I--JZ / Oil, Clearing
End-Dated Code/Description
82K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C
New Code/Description
81K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C
End-Dated Code/Description
88L--KM / Counter, Urine Particle
New Code/Description
81L--KM / Counter, Urine Particle
End-Dated Code/Description
85M--NA / Device, Semen Analysis
New Code/Description
81M--NA / Device, Semen Analysis
End-Dated Code/Description
82O--VQ / Chronic lymphocytic leukemia fish probe kit
New Code/Description
81O--VQ / Chronic lymphocytic leukemia fish probe kit
End-Dated Code/Description
82P--CZ / Investigational use only - Immunology
New Code/Description
81P--CZ / Investigational use only - Immunology
End-Dated Code/Description
73P--HY / Sparse sample PK profile and dosing software
New Code/Description
81P--HY / Sparse sample PK profile and dosing software
End-Dated Code/Description
88I--BB / Phytohemaglutinin M
New Code/Description
82I--BB / Phytohemaglutinin M
End-Dated Code/Description
88K--EF / Paraformaldehyde
New Code/Description
82K--EF / Paraformaldehyde
End-Dated Code/Description
81K--EX / Sorter, Cell
New Code/Description
82K--EX / Sorter, Cell
End-Dated Code/Description
81L--IZ / Assay, T Lymphocyte Surface Marker
New Code/Description
82L--IZ / Assay, T Lymphocyte Surface Marker
End-Dated Code/Description
81L--JD / Assay, B Lymphocyte Marker
New Code/Description
82L--JD / Assay, B Lymphocyte Marker
End-Dated Code/Description
81M--AN / Assay, Interleukin
New Code/Description
82M--AN / Assay, Interleukin
End-Dated Code/Description
81P--DX / Flow cytometry calibrator
New Code/Description
82P--DX / Flow cytometry calibrator
End-Dated Code/Description
83P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System
New Code/Description
82P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System
End-Dated Code/Description
82O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
New Code/Description
83O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
End-Dated Code/Description
73B--WK / Stimulator, Electro-Acupuncture
New Code/Description
84B--WK / Stimulator, Electro-Acupuncture
End-Dated Code/Description
89I--KN / Electromyograph, Diagnostic
New Code/Description
84I--KN / Electromyograph, Diagnostic
End-Dated Code/Description
89I--KT / Electrode, Needle, Diagnostic Electromyograph
New Code/Description
84I--KT / Electrode, Needle, Diagnostic Electromyograph
End-Dated Code/Description
89M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)
New Code/Description
84M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)
End-Dated Code/Description
87O--AN / orthosis, cranial, laser scan
New Code/Description
84O--AN / orthosis, cranial, laser scan
End-Dated Code/Description
77O--RR / Neurological stereotaxic instrument, real-time intraoperative mri
New Code/Description
84O--RR / Neurological stereotaxic instrument, real-time intraoperative mri
End-Dated Code/Description
89O--TX / Foot wrap for treating restless leg syndrome symptoms
New Code/Description
84O--TX / Foot wrap for treating restless leg syndrome symptoms
End-Dated Code/Description
89O--VP / Vibratory counter-stimulation
New Code/Description
84O--VP / Vibratory counter-stimulation
End-Dated Code/Description
89O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)
New Code/Description
84O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)
End-Dated Code/Description
89P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)
New Code/Description
84P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)
End-Dated Code/Description
89P--HL / Powered Exoskeleton
New Code/Description
84P--HL / Powered Exoskeleton
End-Dated Code/Description
78M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
New Code/Description
85M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
End-Dated Code/Description
90N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided
New Code/Description
85N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided
End-Dated Code/Description
74O--SV / Insfufflator, endoscopic vessel harvesting
New Code/Description
85O--SV / Insfufflator, endoscopic vessel harvesting
End-Dated Code/Description
90P--AS / RF/Microwave hyperthermia system, cancer treatment
New Code/Description
85P--AS / RF/Microwave hyperthermia system, cancer treatment
End-Dated Code/Description
78P--SI / Perineal irrigation kit
New Code/Description
85P--SI / Perineal irrigation kit
End-Dated Code/Description
79J--DJ / Prosthesis, Hip, Acetabular Mesh
New Code/Description
87J--DJ / Prosthesis, Hip, Acetabular Mesh
End-Dated Code/Description
79J--DK / Prosthesis, Hip, Cement Restrictor
New Code/Description
87J--DK / Prosthesis, Hip, Cement Restrictor
End-Dated Code/Description
89M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
New Code/Description
87M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
End-Dated Code/Description
89M--BS / Filler, Bone Void, Non-Osteoinduction
New Code/Description
87M--BS / Filler, Bone Void, Non-Osteoinduction
End-Dated Code/Description
89M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
New Code/Description
87M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
End-Dated Code/Description
84O--JP / orthopedic computer controlled surgical system
New Code/Description
87O--JP / orthopedic computer controlled surgical system
End-Dated Code/Description
84O--NN / intraoperative orthopedic joint assessment aid
New Code/Description
87O--NN / intraoperative orthopedic joint assessment aid
End-Dated Code/Description
82D--AA / Igg, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--AA / Igg, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--EY / Igm, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--EY / Igm, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GH / Igd, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--GH / Igd, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GO / Ige, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--GO / Ige, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--HF / D/Km-1, Antigen, Antiserum, Control
New Code/Description
88D--HF / D/Km-1, Antigen, Antiserum, Control
End-Dated Code/Description
81G--IA / Test, Leukocyte Peroxidase
New Code/Description
88G--IA / Test, Leukocyte Peroxidase
End-Dated Code/Description
82L--YE / Cytokeratins
New Code/Description
88L--YE / Cytokeratins
End-Dated Code/Description
81M--AO / DNA-Probe, Human Chromosome
New Code/Description
88M--AO / DNA-Probe, Human Chromosome
End-Dated Code/Description
81M--TI / Kit, Cell Screening, Fetal
New Code/Description
88M--TI / Kit, Cell Screening, Fetal
End-Dated Code/Description
82M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum
New Code/Description
88M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum
End-Dated Code/Description
81N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR
New Code/Description
88N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR
End-Dated Code/Description
81N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR
New Code/Description
88N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR
End-Dated Code/Description
82N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec
New Code/Description
88N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec
End-Dated Code/Description
82N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi
New Code/Description
88N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi
End-Dated Code/Description
82N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test
New Code/Description
88N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test
End-Dated Code/Description
82N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention
New Code/Description
88N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention
End-Dated Code/Description
82N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
New Code/Description
88N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
End-Dated Code/Description
82N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
New Code/Description
88N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
End-Dated Code/Description
82O--QS / Laboratory developed test
New Code/Description
88O--QS / Laboratory developed test
End-Dated Code/Description
82O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
New Code/Description
88O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
End-Dated Code/Description
82O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
New Code/Description
88O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
End-Dated Code/Description
82P--AN / BRAF Mutation Kit
New Code/Description
88P--AN / BRAF Mutation Kit
End-Dated Code/Description
82P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization
New Code/Description
88P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization
End-Dated Code/Description
82P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders
New Code/Description
88P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders
End-Dated Code/Description
82P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc
New Code/Description
88P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc
End-Dated Code/Description
82P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
New Code/Description
88P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
End-Dated Code/Description
81P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
New Code/Description
88P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
End-Dated Code/Description
84G--ZC / Stimulator, Neuromuscular, Implanted
New Code/Description
89G--ZC / Stimulator, Neuromuscular, Implanted
End-Dated Code/Description
87H--SS / Halter, Head, Traction
New Code/Description
89H--SS / Halter, Head, Traction
End-Dated Code/Description
76E--AG / Cephalometer
New Code/Description
90E--AG / Cephalometer
End-Dated Code/Description
76E--AH / Cone, Radiographic, Lead-Lined
New Code/Description
90E--AH / Cone, Radiographic, Lead-Lined
End-Dated Code/Description
76E--AP / Unit, X-Ray, Intraoral
New Code/Description
90E--AP / Unit, X-Ray, Intraoral
End-Dated Code/Description
76E--HB / Collimator, X-Ray
New Code/Description
90E--HB / Collimator, X-Ray
End-Dated Code/Description
76E--HD / Unit, X-Ray, Extraoral With Timer
New Code/Description
90E--HD / Unit, X-Ray, Extraoral With Timer
End-Dated Code/Description
94R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment
New Code/Description
90R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment
End-Dated Code/Description
75P--FT / Reagents for molecular diagnostic test systems
New Code/Description
91P--FT / Reagents for molecular diagnostic test systems
End-Dated Code/Description
75Q--BK / Meprobamate test system
New Code/Description
91Q--BK / Meprobamate test system
End-Dated Code/Description
94R--IK / television, non-CRT, non-medical, video display
New Code/Description
95R--IK / television, non-CRT, non-medical, video display
The Food and Drug Administration will be end-dating duplicate codes, effective in 60 days on _____ ___, 2018. The end-dated code and correct code are listed below.
End-Dated Code/Description
79J--CT/Prosthesis, Tracheal
Correct Code/Description
73J--CT/Prosthesis, tracheal, expandable
End-Dated Code/Description
81P--QD/Blood specimen collection convenience kit (excludes HIV)
Correct Code/Description
75P--QD/Blood specimen collection convenience kit (excludes HIV)
End-Dated Code/Description
81P--OD/Temporary, internal use hemostatic
Correct Code/Description
79P--OD/Temporary, internal use hemostatic
End-Dated Code/Description
78F--EB/Accessories, Cleaning, For Endoscope
Correct Code/Description
80F--EB/Accessories, cleaning, for endoscope
End-Dated Code/Description
79L--HF/Warmer, microwave, infusion fluid
Correct Code/Description
80L--HF/Warmer, microwave, infusion fluid
End-Dated Code/Description
74L--LK/Legging, Compression, Non-inflatable
Correct Code/Description
80L--LK/Legging, compression, non-inflatable
End-Dated Code/Description
78N--VE/Washer, Cleaner, automated, endoscope
Correct Code/Description
80N--VE/Washer, cleaner, automated, endoscope
End-Dated Code/Description
78N--ZA/Accessories, germicide, cleaning, for endoscopes
Correct Code/Description
80N--ZA/Accessories, germicide, cleaning, for endoscopes
End-Dated Code/Description
79O--FP/Basic set-up tray
Correct Code/Description
80O--FP/Anesthesia breathing circuit kit (adult & pediatric)
End-Dated Code/Description
81N--ID/Assay, Proliferation, In Vitro, T Lymphocyte
Correct Code/Description
82N--ID/Assay, Interleukin
End-Dated Code/Description
92O--WD/Somatic gene mutation detection system
Correct Code/Description
82O--WD/Somatic gene mutation detection system
End-Dated Code/Description
87H--RW/Dynamometer, nonpowered
Correct Code/Description
84H--RW/Dynamometer, nonpowered
End-Dated Code/Description
87H--ST/Apparatus, traction, non-powered
Correct Code/Description
84H--ST/Apparatus, traction, non-powered
End-Dated Code/Description
87K--QW/Goniometer, nonpowered
Correct Code/Description
84K--QW/Goniometer, nonpowered
End-Dated Code/Description
87K--QX/Goniometer, Ac-Powered
Correct Code/Description
84K--QX/Goniometer, ac-powered
End-Dated Code/Description
87L--BB/Dynamometer, Ac-Powered
Correct Code/Description
84L--BB/Dynamometer, ac-powered
End-Dated Code/Description
87L--YH/Arthrometer
Correct Code/Description
84L--YH/Arthrometer
End-Dated Code/Description
89N--HH/Device, discharge, electrostatic (for pain relief)
Correct Code/Description
84N--HH/Device, Discharge, Electrostatic (for Pain Relief)
End-Dated Code/Description
87N--KI/Goniometer with Electrodes
Correct Code/Description
84N--KI/Goniometer with electrodes
End-Dated Code/Description
86O--PT/INFRARED HEMATOMA DETECTOR
Correct Code/Description
84O--PT/INFRARED HEMATOMA DETECTOR
End-Dated Code/Description
78O--AC/plethysmograph, air displacement for body composition analysis
Correct Code/Description
85O--AC/plethysmograph, air displacement for body composition analysis
End-Dated Code/Description
89H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
Correct Code/Description
87H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
End-Dated Code/Description
92P--ZM/Next generation sequencing based tumor profiling test
Correct Code/Description
88P--ZM/Next generation sequencing based tumor profiling test
End-Dated Code/Description
95R--GC/X-Ray Field Indicator Light (Laser), Positioning Medical Laser Products
Correct Code/Description
90R--GC/X-ray field indicator light (laser)
The Food and Drug administration will be end-dating CDRH product codes, effective in 60 days on November 5, 2018. The end-dated codes are listed below.
End-Dated Code/Description
73K--GA/Cylinder, Gas(Empty)
End-Dated Code/Description
74L--IS/Heparin Coating Chemicals
End-Dated Code/Description
74L--IW/Fibrillator, AC
End-Dated Code/Description
74L--OS/System, ECG Analysis
End-Dated Code/Description
74M--NN/Device, Ablation, Varicose Vein
End-Dated Code/Description
74N--PN/Defibrillator, Automatic, External, for Out-of-Hospital Use
End-Dated Code/Description
74O--VW/Active compression/decompression pump
End-Dated Code/Description
75P--QW/alpha-D-galactosidase A (GLA) newborn screening test system
End-Dated Code/Description
76E--CF/Sterilizer, Dry Heat, Endodontic
End-Dated Code/Description
77E--NL/Nasograph
End-Dated Code/Description
77E--TL/Nasal Flowmeter
End-Dated Code/Description
77J--CS/Prosthesis, Maxilla
End-Dated Code/Description
77K--HK/Polymer, Ent Natural-Collagen Material
End-Dated Code/Description
77M--GF/Collagen, Injectable For Vocal Cord Augmentation
End-Dated Code/Description
78F--TK/Pancreatoscope, Biliary
End-Dated Code/Description
78K--OG/Endoscope And/Or Accessories
End-Dated Code/Description
78K--PG/Magnet, Continent Colostomy
End-Dated Code/Description
78L--NN/Device, Anastomosis for Gastro-Urology Use
End-Dated Code/Description
78L--TH/Graft, Vascular Access
End-Dated Code/Description
78N--NF/Set, Dialysis, Single needle (co-axial flow), Reprocessed
End-Dated Code/Description
78Q--AM/Apheresis for focal glomerulosclerosis for adult and pediatric patients
End-Dated Code/Description
79E--SY/Prosthesis, Otoplasty
End-Dated Code/Description
79K--DB/Instrument, Disposal, Surgical (Sharps)
End-Dated Code/Description
80L--DQ/Device, General Medical
End-Dated Code/Description
80N--PC/Glove, Patient Examination, Powder Free
End-Dated Code/Description
83P--RD/Biothreat microbial agents multiplex nucleic acid detection system
End-Dated Code/Description
83P--RH/Positive blood culture identification and AST kit
End-Dated Code/Description
84M--QD/Electrode, Cone, Implantable
End-Dated Code/Description
85M--MN/Ductoscope, Breast
End-Dated Code/Description
85N--HR/Material, Implant, Uterine, for Adhesiogenic Effect
End-Dated Code/Description
85N--MO/Needle, Aspiration, Oocyte, Reprocessed
End-Dated Code/Description
86O--RS/Magnetotherapy device for pain relief
End-Dated Code/Description
87M--CJ/Pump, Vacuum, Electric, Suction-Type Electrode
End-Dated Code/Description
89I--PQ/Control, Hand Driving, Automobile, Mechanical
End-Dated Code/Description
89P--GA/Electroporation, transdermal delivery
End-Dated Code/Description
91N--ED/Kit, Test, Malaria
End-Dated Code/Description
95R--FH/UV Curing, Material Processing Laser Products
End-Dated Code/Description
95R--GR/Air Purifier, Ultraviolet Commercial/Consumer
End-Dated Code/Description
95R--ZN/General Industrial Use Material Processing Laser Products
End-Dated Code/Description
95R--ZP/Home/Office Machine Incorporating, Utility/Peripheral Laser
End-Dated Code/Description
95R--ZS/Positioning Medical Laser Product
The Food and Drug administration has created new CDRH product codes, effective immediately. The product codes are listed below.
New Code/Description
73Q—AV/ High flow/high velocity humidified oxygen delivery device
New Code/Description
73Q—BY/ Positive airway pressure system
New Code/Description
74N—PU/ Prosthesis, Mitral Valve, Percutaneously Delivered
New Code/Description
74Q—BI/ Acute coronary syndrome event detector
New Code/Description
83P—RA/ Variola virus nucleic acid-based detection assay
New Code/Description
91P—RF/ Docetaxel / Paclitaxel assay
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov. For questions or concerns regarding ACE, contact ACE_Support@fda.hhs.gov.
CSMS #18-000652