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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One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 pH/CRE/SG.
BTNX Inc
D12.5.1-1VA
In Commercial Distribution

  • 00722066005675 ()
  • 10722066005672 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10M5
Not in Commercial Distribution

  • 00816565020359 ()
IMCA-10M5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 10 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<MDMA>+<OXY>+(AMP/COC)+(MET/MOP/PCP)+(BZO/MTD/BAR)
Instant Technologies, Inc.
DUE-1107-541
In Commercial Distribution

  • 10817405024084 ()
  • 00817405024087 ()
DUE-1107-541

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 PANEL CLIA WAIVED ROUND CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 + CR, pH, S.G.
Instant Technologies, Inc.
ABTDUAW113701A
In Commercial Distribution

  • 10817405023308 ()
  • 00817405023301 ()
  • 30817405023302 ()
ABTDUAW113701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Multi-Drug Urine Test Cup with Adulterants (CR, NI, pH, OX, SG) 7 panel AMP1000, COC300, MET500, OPI300, OXY100, PCP25, THC50
Instant Technologies, Inc.
TDOA-7A
In Commercial Distribution

  • 00817405021086 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOP/MTD/OXY/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-41107-0-A
In Commercial Distribution

  • 00816036026576 ()
  • 00816036027078 ()
SCP-41107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC + CR,OX,pH, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-31107-0-A
In Commercial Distribution

  • 00816036026569 ()
  • 00816036027061 ()
SCP-31107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II, 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-71127
In Commercial Distribution

  • 00816036020932 ()
  • 00816036021144 ()
STATII-71127

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel Urine Drug Screen Cup, AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50, Adulterants (OX/SG/pH).
HENRY SCHEIN, INC.
5703927
In Commercial Distribution

  • 00304040186732 ()
  • 10304040186739 ()
5703927

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 00812125010051 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 10812125010058 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 1 3/4 in (45 mm)
CONVATEC, PURCHASING DEPARTMENT
175772
Not in Commercial Distribution

  • 10768455102492 ()
  • 00768455102495 ()
  • 80768455102491 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 1 1/2 in (38 mm)
CONVATEC, PURCHASING DEPARTMENT
175771
Not in Commercial Distribution

  • 10768455102485 ()
  • 00768455102488 ()
  • 80768455102484 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter. with One Sided Comfort Panel, Opaque, 1 1/4 in (32 mm)
CONVATEC, PURCHASING DEPARTMENT
175770
Not in Commercial Distribution

  • 10768455102478 ()
  • 00768455102471 ()
  • 80768455102477 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 3/4 in (45 mm)
CONVATEC, PURCHASING DEPARTMENT
175765
Not in Commercial Distribution

  • 10768455102416 ()
  • 00768455102419 ()
  • 80768455102415 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 1/2 in (38 mm)
CONVATEC, PURCHASING DEPARTMENT
175764
Not in Commercial Distribution

  • 10768455102409 ()
  • 00768455102402 ()
  • 80768455102408 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 1/4 in (32 mm)
CONVATEC, PURCHASING DEPARTMENT
175763
Not in Commercial Distribution

  • 10768455102393 ()
  • 00768455102396 ()
  • 80768455102392 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 3/4" (19Mm.)
CONVATEC, PURCHASING DEPARTMENT
125338
In Commercial Distribution

  • 10768455101990 ()
  • 00768455101993 ()
  • 00768455180523 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 3/4" (19Mm.)
CONVATEC, PURCHASING DEPARTMENT
125331
In Commercial Distribution

  • 10768455101921 ()
  • 00768455101924 ()
  • 00768455180462 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022769
In Commercial Distribution

  • 10768455101594 ()
  • 00768455101597 ()
  • 00768455179237 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022765
In Commercial Distribution

  • 10768455101556 ()
  • 00768455101559 ()
  • 00768455179190 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Opaque, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022762
In Commercial Distribution

  • 10768455101525 ()
  • 00768455101528 ()
  • 00768455179169 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022758
In Commercial Distribution

  • 10768455101488 ()
  • 00768455101481 ()
  • 00768455179121 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 10" Opaque, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022755
In Commercial Distribution

  • 10768455101457 ()
  • 00768455101450 ()
  • 00768455179091 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 10" Opaque, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022751
In Commercial Distribution

  • 10768455101419 ()
  • 00768455101412 ()
  • 00768455179053 ()


  • One-piece intestinal ostomy bag, open-ended
DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+<PPX> 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN 10869419000219)
Quest Diagnostics
UDOA-10CA-0503-01
In Commercial Distribution

  • 00869419000212 ()
  • 20869419000230 ()
DUA-1107-061-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Esteem®+ One-Piece Drainable Cut-To-Fit, Clipped, Modified Stomahesive® With Filter, 1 Comfort Panel,Standard 12", Transparent 13/16-2 3/4", 20-70Mm
CONVATEC, PURCHASING DEPARTMENT
421848
In Commercial Distribution

  • 10768455153166 ()
  • 00768455153169 ()
  • 00768455172580 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
650830
In Commercial Distribution

  • 10768455106636 ()
  • 00768455106639 ()
  • 00768455190249 ()


  • One-piece intestinal ostomy bag, open-ended
(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - AMP500, BZO300, COC150, MOR/OPI300, OXY100, THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US6
In Commercial Distribution

  • 20850721007949 ()
  • 10850721007942 ()
  • 00850721007945 ()
ID-US6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip
MEDICAL DISTRIBUTION GROUP INC
ID-H13-1
In Commercial Distribution

  • 10850013035028 ()
  • 00850721007105 ()
ID-H13-1

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC ; Adulterants: +pH, OX,SG
MERCEDES MEDICAL, LLC
TNR CDOA5125A3
In Commercial Distribution

  • 00850011007075 ()
  • 10850011007072 ()
  • 20850011007079 ()
TNR CDOA5125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, 2XL
STANDARD TEXTILE CO., INC.
75674913
In Commercial Distribution

  • 10634916797173 ()
  • 00634916797176 ()


  • Surgical gown, reusable
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, X-Large
STANDARD TEXTILE CO., INC.
75674914
In Commercial Distribution

  • 10634916797166 ()
  • 00634916797169 ()


  • Surgical gown, reusable
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Large
STANDARD TEXTILE CO., INC.
75674915
In Commercial Distribution

  • 10634916797159 ()
  • 00634916797152 ()


  • Surgical gown, reusable
The Radlink GPS Bucky Cart is a manually operated cart with one compartment that is meant for housing and transporting flat panel detectors.
RADLINK, INC.
Bucky
In Commercial Distribution

  • 00866389000136 ()


  • X-ray film cassette holder
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOBCLIA
Not in Commercial Distribution

  • 00858998006180 ()
USSCupA-7MOBCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605211
In Commercial Distribution

  • 10690286000695 ()
  • 00690286000698 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)+ (OXI-SG-PH)
Medical Disposables Corp
MDC-6125R-A3
In Commercial Distribution

  • 00860003196977 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)+ (OXI-SG-PH)
Medical Disposables Corp
MDC-6125R-A3
In Commercial Distribution

  • 00860003196960 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)+ (OXI-SG-PH)
Medical Disposables Corp
MDC-6125R-A3
In Commercial Distribution

  • 00860003196946 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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