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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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HarmonyAIR - 00724995165710

The Air Single M7 High Density with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165710 ()
LMH09N

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

Setmark Incorporated - 00854204008412

Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300lb capacity
SETMARK INC.
NF-100
In Commercial Distribution

  • 00854204008412 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

CRL STAT Dip Card - 00817815020907

CRL STAT 8 Panel Dip - KCUR920121 AMP1000/BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (CR/NI/OX/PH/SG)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920121
In Commercial Distribution

  • 00817815020907 ()


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

CRL STAT Cup - 00817815021324

CRL STAT 10 panel Cup - KCUR920110 BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OXY100/PCP25/THC50 (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920110
In Commercial Distribution

  • 00817815021324 ()


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

Healgen (Private Label) - 6124 - 00895330002561

Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6124
In Commercial Distribution

  • 00895330002561 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent

Healgen (Private Label) - 3124 - 00895330002547

Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MTD300/MOP2000/OXY100/PCP25/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3124
In Commercial Distribution

  • 00895330002547 ()


  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Nortriptyline IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent

Healgen (Private Label) - 6125 - 00895330002639

Healgen (DrugConfirm) - 12 Panel CLIA Dip Card AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-6125
In Commercial Distribution

  • 00895330002639 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • 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
  • Opiate/opiate metabolite IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) - 6124 - 00895330002615

Healgen (DrugConfirm) - 12 Panel Dip Card CLIA AMP1000/BAR300/BUP10/BZO300/COC300/THC50/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-9124
In Commercial Distribution

  • 00895330002615 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent

Sterile Labels - 10849771043178

Sterile Labels, 10 labels per panel, 2 panels per pouch, 100 packages per box, Custom Medical Labels for CAME017
KEY SURGICAL, INC.
SL212
In Commercial Distribution

  • 50849771043176 ()
  • 10849771043178 ()
  • 00849771043171 ()
SL212

  • Procedural medication labelling set

UCP Home Drug Screening Test Cups - 10817038020644

13 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/BUP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-8134-RCN
In Commercial Distribution

  • 20817038020641 ()
  • 10817038020644 ()
  • 00817038020647 ()
U-CUP-8134-RCN

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