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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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MD DrugScreen - 00860003196922

CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)
Medical Disposables Corp
MDC-6125R
In Commercial Distribution

  • 00860003196922 ()


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

MD DrugScreen - 00860003196915

CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)
Medical Disposables Corp
MDC-6125R
In Commercial Distribution

  • 00860003196915 ()


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

U-Screen - 00858998006142

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Tech Subsidiary Acquisition
USSCupA-5M
Not in Commercial Distribution

  • 00858998006142 ()
USSCupA-5M

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

U-Screen - 00858998006012

U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Tech Subsidiary Acquisition
USSCup-10M
Not in Commercial Distribution

  • 00858998006012 ()
USSCup-10M

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

NexScreen Drug Dip Card - 00858984006323

NexScreen Drug Dip Card 12 Panel (PPX) BZO300/BAR300/COC150/THC50/MET500/OPI2000/ MTD300/OXY100/MDMA500/PCP25/AMP500/PPX300
NEXSCREEN, LLC
NCard-12-PPX
In Commercial Distribution

  • 00858984006323 ()
NCard-12-PPX

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

HarmonyAIR - 00724995192235

The G5 Single Light Hybrid Extension, Camera, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192235 ()
LGH25

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

HarmonyAIR - 00724995191863

The Secondary Spindle Dual/Extension Arm with Dual Flat Panel Monitor is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995191863 ()
LM0032

  • Medical monitor/light mount

HarmonyAIR - 00724995190163

The A-Series Spindle Single Light Single Flat Panel Monitor High Density is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190163 ()
LAH000004

  • Medical monitor/light mount

HarmonyAIR - 00724995190132

The A-Series Spindle Dual Light Single Flat Panel Monitor High Density is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190132 ()
LAH000001

  • Medical monitor/light mount

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

Identify Health - 10850013035301

Identify Health 4 Panel Drug Test Dip- CLIA Waived AMP500, COC150, MOP300, PCP25 Approx. 3.0mm strip 25 Tests/Box
MEDICAL DISTRIBUTION GROUP INC
ID-H4-DIP-1-AZ25
In Commercial Distribution

  • 00850013035304 ()
  • 10850013035301 ()
ID-H4-DIP-1-AZ25

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

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

Verify - G474MV002110001EI0

mLife Verify 11 Panel Oral Fluid Drug Test FYL AMP COC MET OPI THC BAR BZO MDMA OXY PCP
Mlife Diagnostics, LLC
MV002.11.0001EI
In Commercial Distribution

  • G474MV002110001EI0 ()


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

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

u-Card Drug Test Screen - 10817038021900

u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA)
UCP BIOSCIENCES, INC.
UDO-6123
In Commercial Distribution

  • 20817038021907 ()
  • 10817038021900 ()
  • 00817038021903 ()
UDO-6123

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

u-Cup Drug Test Screen - 10817038021863

u-Cup Drug Test Screen 10 Panel Drug Test Cup (BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC)
UCP BIOSCIENCES, INC.
U-CUP-7104
In Commercial Distribution

  • 20817038021860 ()
  • 10817038021863 ()
  • 00817038021866 ()
U-CUP-7104

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

Rapid Response - 10722066007546

12 Panel One Step DOA Cup (12.5) - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 PCP25
BTNX Inc
D12.5-1VF
In Commercial Distribution

  • 00722066007549 ()
  • 10722066007546 ()


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

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

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

Rite Aid - 00011822001670

Home Drug Test 14 Panel THC/COC/PCP/mAMP/AMP/MDMA/TCA/BAR/BZO/MTD/OXY/PPX/BUP/OPI
RITE AID CORPORATION
8024512
In Commercial Distribution

  • 00011822001670 ()


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

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

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

UScreen® - 00817405021154

U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Technologies, Inc.
USSCup-10M
In Commercial Distribution

USSCup-10M

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

UScreen® - 00817405021130

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCupA-5M
In Commercial Distribution

USSCupA-5M

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

iScreen™ - 00817405023424

7 PANEL CLIA WAIVED ROUND CUP AMP1000, COC300, MET500, MOP300, OXY100, PCP25, THC50 SVT (CR, NI, OX, pH, S.G.)
Instant Technologies, Inc.
ABTDUAW17703C
In Commercial Distribution

  • 30817405023425 ()
  • 00817405023424 ()
  • 10817405023421 ()
ABTDUAW17703C

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

STATCUP® - 00816036026620

STATCUP 7 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2277-0-A
In Commercial Distribution

  • 00816036027122 ()
  • 00816036026620 ()
SCP-2277-0-A

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

FASTEST LABS - 00816036025166

FASTEST 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
FST-71127-0
In Commercial Distribution

  • 00816036025166 ()
  • 00816036025326 ()
FST-71127-0

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

STATCUP® II - 00816036025074

STATCUP II 8 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2387-0-A
In Commercial Distribution

  • 00816036025074 ()
  • 00816036025234 ()
STATⅡ-2387-0-A

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

ImmuTest Drugs of Abuse Cup - 00816565020250

7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-7P
Not in Commercial Distribution

  • 00816565020250 ()
IMCA-7P

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

ImmuTest Drugs of Abuse Cup - 00816565020205

5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-5AB-W
Not in Commercial Distribution

  • 00816565020205 ()
IMCA-5AB-W

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

CLIAwaived - 00816610020921

CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO) -(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-7-60717
In Commercial Distribution

  • 00816610020921 ()
CLIA-IDTC-7-60717

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

Fastep - 00810022630402

Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
Azure Biotech, Inc.
AZC-8105
In Commercial Distribution

  • 00810022630402 ()


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

Express ResultsTM - 20869419000209

DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
Quest Diagnostics
UDOA-6CA-0503-01
In Commercial Distribution

  • 00869419000205 ()
  • 20869419000209 ()
DUA-167-012-19-ONW504A

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

ESTEEM+ - 00768455112135

Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416743
In Commercial Distribution

  • 10768455112132 ()
  • 00768455112135 ()
  • 00768455188529 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455112128

Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416742
In Commercial Distribution

  • 10768455112125 ()
  • 00768455112128 ()
  • 00768455188512 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455111954

Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416725
In Commercial Distribution

  • 10768455111951 ()
  • 00768455111954 ()
  • 00768455188383 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455111947

Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Transparent, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416724
In Commercial Distribution

  • 10768455111944 ()
  • 00768455111947 ()
  • 00768455188376 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455101917

Activelife® One-Piece Drainable Cut-To-Fit Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Trans
CONVATEC, PURCHASING DEPARTMENT
125330
In Commercial Distribution

  • 10768455101914 ()
  • 00768455101917 ()
  • 00768455180455 ()


  • One-piece intestinal ostomy bag, open-ended

EasyScreen™ Gastrointestinal Parasite PCR Positive Control - 09351179004070

The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
GENETIC SIGNATURES LIMITED
1
In Commercial Distribution

  • 09351179004070 ()
PC-PROT-001

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

CR-IR 392 - 04547410472905

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472905 ()


  • Computed radiography digital imaging scanner

CR-IR 392 - 04547410472882

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472882 ()


  • Computed radiography digital imaging scanner

CR-IR 392 - 04547410343816

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410343816 ()


  • Computed radiography digital imaging scanner

BioCode MDx 3000 - 00851034007004

The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007004 ()
41-A0051

  • Microplate reader IVD, automated/semi-automated

Discovery - 00840682115322

XR656 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682115322 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00840682138598

Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital

Shiga Toxin Direct Test - B178GBSTEC100

Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BD Pre-warm Heater - 00382904431594

KIT PREWARM MAX6
BECTON, DICKINSON AND COMPANY
443159
In Commercial Distribution

  • 00382904431594 ()
443159

  • Test tube heater

Definium - 00195278118356

Definium Tempo System UDI
GE Hualun Medical Systems Co., Ltd
Tempo
In Commercial Distribution

  • 00195278118356 ()
B2401CAB

  • Stationary basic diagnostic x-ray system, digital
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