Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BUP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BUP-114
In Commercial Distribution

  • 20817038020511 ()
  • 10817038020514 ()
  • 00817038020517 ()
U-BUP-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-THC-114
In Commercial Distribution

  • 20817038020504 ()
  • 10817038020507 ()
  • 00817038020500 ()
U-THC-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
OPI300 Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MOP-114
In Commercial Distribution

  • 20817038020467 ()
  • 10817038020460 ()
  • 00817038020463 ()
U-MOP-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
MTD Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MTD-114
In Commercial Distribution

  • 20817038020450 ()
  • 10817038020453 ()
  • 00817038020456 ()
U-MTD-114

  • Methadone IVD, kit, rapid ICT, clinical
COC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-COC-114
In Commercial Distribution

  • 20817038020443 ()
  • 10817038020446 ()
  • 00817038020449 ()
U-COC-114

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
BZO Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BZO-114
In Commercial Distribution

  • 20817038020436 ()
  • 10817038020439 ()
  • 00817038020432 ()
U-BZO-114

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
AMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-AMP-114
In Commercial Distribution

  • 20817038020429 ()
  • 10817038020422 ()
  • 00817038020425 ()
U-AMP-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
mAMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MET-114
In Commercial Distribution

  • 20817038020412 ()
  • 10817038020415 ()
  • 00817038020418 ()
U-MET-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114
In Commercial Distribution

  • 20817038020405 ()
  • 10817038020408 ()
  • 00817038020401 ()
U-MDMA-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
PCP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-PCP-114
In Commercial Distribution

  • 20817038020399 ()
  • 10817038020392 ()
  • 00817038020395 ()
U-PCP-114

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114
In Commercial Distribution

  • 20817038020382 ()
  • 10817038020385 ()
  • 00817038020388 ()
U-BAR-114

  • Barbiturate IVD, kit, rapid ICT, clinical
TCA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-TCA-114
In Commercial Distribution

  • 20817038020023 ()
  • 10817038020026 ()
  • 00817038020029 ()
U-TCA-114

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
PPX Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-PPX-114
In Commercial Distribution

  • 20817038020016 ()
  • 10817038020019 ()
  • 00817038020012 ()
U-PPX-114

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
OXY Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OXY-114
In Commercial Distribution

  • 20817038020009 ()
  • 10817038020002 ()
  • 00817038020005 ()
U-OXY-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Flat Panel Digital Medical X-Ray Detector.
Imaging Dynamics Company Ltd
1417WCI
In Commercial Distribution

  • 00823073005211 ()

  • Weight: 3.6 Kilogram
  • Height: 15.2 Millimeter
  • Width: 384 Millimeter
  • Length: 460 Millimeter


  • Diagnostic x-ray digital imaging conversion system
Alere Triage® Cardiac Panel, TnI
ALERE SAN DIEGO, INC.
97021HS
Not in Commercial Distribution

  • 00899722002788 ()
97021HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Medical Grade Flat Panel Monitor, 21"
BR Surgical, LLC
BR900-4421
In Commercial Distribution

  • 00840183509347 ()
BR900-4421

  • Image display unit, colour
HYDRATHERM CONTROL PANEL SCREW REPAIR PART
COMPASS HEALTH BRANDS CORP.
HT-TU-CNTRLPNLS
In Commercial Distribution

  • 00092237626009 ()


  • Hot therapy pack heating unit
Home Drug Test 1 Panel THC
RITE AID CORPORATION
8024513
In Commercial Distribution

  • 00011822001656 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
8 panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-8XT-030
In Commercial Distribution

  • 10694644100225 ()
  • 10694644150220 ()
10-8XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS
AMD Medicom Inc
2213-BL
In Commercial Distribution

  • 20686864048033 ()
  • 10686864048036 ()
  • 00686864048039 ()
2213-BL

  • Surgical sponge-counting tray
AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS
AMD Medicom Inc
2213
In Commercial Distribution

  • 20686864048026 ()
  • 10686864048029 ()
  • 00686864048022 ()
2213

  • Surgical sponge-counting tray
2 panel InCup w/THC & Meth
AMERICAN BIO MEDICA CORPORATION
10-2MC-000
In Commercial Distribution

  • 10694644400141 ()
  • 10694644450146 ()
10-2MC-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Panel with BZO, 300ng OPI
AMERICAN BIO MEDICA CORPORATION
10-5Z1-030
In Commercial Distribution

  • 10694644300458 ()
  • 10694644350453 ()
10-5Z1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 PANEL W/METH,OXY, OPI300
AMERICAN BIO MEDICA CORPORATION
10-5MO1-030
In Commercial Distribution

  • 10694644300281 ()
  • 10694644350286 ()
10-5MO1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Coc & Meth Single
AMERICAN BIO MEDICA CORPORATION
10-2CM1-000
In Commercial Distribution

  • 10694644300083 ()
  • 10694644350088 ()
10-2CM1-000

  • Oxycodone IVD, calibrator
10 panel RAPIDTOX CUP II: AMP
AMERICAN BIO MEDICA CORPORATION
10-10XX2AB-030
In Commercial Distribution

  • 10694644200369 ()
  • 10694644250364 ()
10-10XX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 2000
AMERICAN BIO MEDICA CORPORATION
10-10XT-200
In Commercial Distribution

  • 10694644100041 ()
  • 10694644150046 ()
10-10XT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-10XT-030
In Commercial Distribution

  • 10694644100034 ()
  • 10694644150039 ()
10-10XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
BIPOLAR SOCKET, NEW STYLE PANEL MOUNTED
ELMED INCORPORATED
5-001
In Commercial Distribution

  • 00198506074097 ()
5-001

  • Electrosurgical cable adaptor
PANEL 04 COC150/AMP1000/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020199
In Commercial Distribution

  • 10858904006584 ()
  • 00858904006587 ()
DOA-144-1041

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 04 COC150/ THC/MOP300/MAMP500
REDWOOD TOXICOLOGY LABORATORY, INC.
011020195
In Commercial Distribution

  • 10858904006577 ()
  • 00858904006570 ()
DOA-144-621

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 4 COC/M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020012
In Commercial Distribution

  • 10858904006225 ()
  • 00858904006228 ()
DOA-344-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC
In Commercial Distribution

  • 20850721007369 ()
  • 10850721007362 ()
  • 00850721007365 ()
ID-THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
U-THC-114
In Commercial Distribution

  • 10850721007027 ()
  • 00850721007020 ()
  • 20850721007024 ()
U-THC-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
PANEL 4 COC/AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020032
In Commercial Distribution

  • 10858904006232 ()
  • 00858904006235 ()
DOA-844-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Visual-ICE™ MRI Mobile Connection Panel
BOSTON SCIENTIFIC CORPORATION
H7493970071000
In Commercial Distribution

H7493970071000

  • General cryosurgical system, cryogen gas, electronic
KIT, DOOR PANEL w' QUIKCLOT - BLK
NORTH AMERICAN RESCUE, LLC
80-1167
In Commercial Distribution

  • 00842209119004 ()
80-1167

  • First aid kit, medicated
KIT, TORK w' DETACH PANEL - BLK
NORTH AMERICAN RESCUE, LLC
85-1946
In Commercial Distribution

  • 00842209106899 ()
85-1946

  • First aid kit, non-medicated, single-use
Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
85-11398
In Commercial Distribution

  • M70883113970 ()
  • M70885113983 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
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