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 Class Implantable

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Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable
No Description
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
BM1000C
In Commercial Distribution

  • 06924054330026 ()


  • Pulse oximeter
No Description
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
BM1000A
In Commercial Distribution

  • 06924054330002 ()


  • Pulse oximeter
No Description
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
BM2000A
In Commercial Distribution

  • 06924054320003 ()


  • Pulse oximeter
No Description
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
BM1000
In Commercial Distribution

  • 06924054330088 ()


  • Pulse oximeter
Healgen (DrugConfirm) - 10 Panel Dip Card - BAR300/BUP10/BZO300/COC300/mAMP1000/MTD300/MOP2000/OXY100/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002820 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Nortriptyline IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
ABTDOAO114701A, 1T/kit, AMP500/BAR300/BUP10/BZO300/COC150/FYL1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177245 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12NTCLIA
In Commercial Distribution

USSCUPA12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Compact Multi-Drug Urine Test Cup <AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000>
Instant Technologies, Inc.
ACDOA-2115
In Commercial Distribution

  • 00817405021031 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW112704D
In Commercial Distribution

  • 30817405023388 ()
  • 00817405023387 ()
  • 10817405023384 ()
ABTDUAW112704D

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