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 9 Panel DOA Cup(9.11) - AMP1000, BUP10, BZO300, COC300, MTD300, MET1000, OPI2000, OXY100, THC50
BTNX Inc
D9.11-1V
In Commercial Distribution

  • 00722066004678 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Drug Test Panel - 25/kit(10.22) - COC300 AMP1000 MET1000 THC50 MTD300 MOP300 OXY100 BAR300 BZO300 BUP10
BTNX Inc
D10.22-1P29-25
In Commercial Distribution

  • 00722066004593 ()
  • 00722066004609 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC With Adulterants
MERGERS MARKETING, INC.
CSC-254AD
In Commercial Distribution

  • 10850557007857 ()
  • 00850557007850 ()
  • 00850557007843 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-564
In Commercial Distribution

  • 10850557007291 ()
  • 00850557007294 ()
  • 00850557007287 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-264
In Commercial Distribution

  • 00850557007164 ()
  • 00850557007171 ()
  • 10850557007178 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Pre Screen Plus Dip Card (CLIA Waived) Drug Combo: COC | MDMA | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-1554
In Commercial Distribution

  • 10850557007130 ()
  • 00850557007133 ()
  • 00850557007126 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Pre Screen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-154
In Commercial Distribution

  • 00850557007102 ()
  • 00850557007119 ()
  • 10850557007116 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: COC|AMP|MET|THC|OPI|PCP
MERGERS MARKETING, INC.
PS-DOA-164
In Commercial Distribution

  • 20851000007155 ()
  • 10851000007158 ()
  • 00851000007151 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC With Alcohol
MERGERS MARKETING, INC.
PSC-DOA-254A
In Commercial Distribution

  • 10851000007059 ()
  • 00851000007052 ()
  • 00851000007045 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 10 Panel Cup Test: AMP1000/mAMP1000/BAR300/BZO300/COC300/MTD300/MDMA500/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6104
In Commercial Distribution

  • 00856464008386 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methadone IVD, reagent
NexScreen Drug Dip Card 9 Panel (6AM) 6AM10/AMP500/COC150/MDMA500/MET500/ MOR300/OXY100/PCP25/THC50
NEXSCREEN, LLC
NCard-09-6AM
In Commercial Distribution

  • 00858984006293 ()
NCard-09-6AM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002076 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002069 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002052 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002045 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002038 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002021 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR G-Series Spring, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995207397 ()
LG000001V

  • Medical monitor/light mount
HarmonyAIR A-Series Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203245 ()
LAS14

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2184BC-G
In Commercial Distribution

  • D0692184BCG0 ()


  • Dental delivery system
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2184BC-C
In Commercial Distribution

  • D0692184BCC0 ()


  • Dental delivery system
OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector) Drape, Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31047
In Commercial Distribution

  • 10618125190826 ()
  • 00618125190812 ()
8849416

  • Medical equipment/instrument drape, single-use
Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3104
In Commercial Distribution

  • 00895330002769 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
10 Panel Flat-Cup w/ADU COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP+A3
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-8104A3
In Commercial Distribution

  • 00895330002745 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BUP10/ BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-8104
In Commercial Distribution

  • 00895330002677 ()


  • Amphetamine/methamphetamine group 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
  • Cannabinoid/cannabinoid metabolite IVD, reagent
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
Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ25
In Commercial Distribution

  • 20850721007673 ()
  • 10850721007676 ()
  • 00850721007679 ()
ID-CP5-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ5
In Commercial Distribution

  • 20850721007505 ()
  • 10850721007508 ()
  • 00850721007501 ()
ID-CP5-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-6104-RCN
In Commercial Distribution

  • 20850721007055 ()
  • 10850721007058 ()
  • 00850721007051 ()
U-CUP-6104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ10
In Commercial Distribution

  • 20850721007611 ()
  • 10850721007614 ()
  • 00850721007617 ()
ID-CP5-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Sterile Labels - Custom TNHO0004, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL214
In Commercial Distribution

  • 20849771052924 ()
  • 10849771052927 ()
  • 00849771052920 ()
SL214

  • Procedural medication labelling set
Sterile Labels - Custom FLHU009, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL213
In Commercial Distribution

  • 20849771052917 ()
  • 10849771052910 ()
  • 00849771052913 ()
SL213

  • Procedural medication labelling set
Sterile Labels - Custom MATR002, 10 labels per panel, 4 panels per pouch, 100 packages per box.
KEY SURGICAL, INC.
SL402
In Commercial Distribution

  • 20849771040013 ()
  • 10849771040016 ()
  • 00849771040019 ()
SL402

  • Procedural medication labelling set
Sterile Labels - Custom INBL005, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL215
In Commercial Distribution

  • 20849771040006 ()
  • 10849771040009 ()
  • 00849771040002 ()
SL215

  • Procedural medication labelling set
Sterile Labels - Sterile Labels -10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050723 ()
  • 10849771050725 ()
  • 00849771050728 ()
  • 00849771032922 ()
SL203

  • Procedural medication labelling set
PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card TM Drug Test Screen 7 panel Test Card COC/AMP/MET/THC/OPI/BZO/OXY
UCP BIOSCIENCES, INC.
U-DOA-374L
In Commercial Distribution

  • 10817038022013 ()
  • 00817038022016 ()
  • 20817038022010 ()
U-DOA-374L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET
UCP BIOSCIENCES, INC.
U-CUP-564
In Commercial Distribution

  • 20817038021945 ()
  • 10817038021948 ()
  • 00817038021941 ()
U-CUP-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-6124L
In Commercial Distribution

  • 20817038021358 ()
  • 10817038021351 ()
  • 00817038021354 ()
U-DOA-6124L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-254
In Commercial Distribution

  • 20817038021280 ()
  • 10817038021283 ()
  • 00817038021286 ()
U-DUD-254

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