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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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DrugConfirm™ 4 Panel Instant Drug Test - 00895330002318

This urine test kit detects 4 drugs: Cocaine (COC), Marijuana (THC), Opiates (OPI) including Heroin, Amphetamines (AMP)
CONFIRM BIOSCIENCES, INC.
03-5201
In Commercial Distribution

  • 00895330002318 ()


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

DrugConfirm™ 12 Panel Instant Drug Test - 00895330002288

his kit tests for 12 Drugs including Prescription Drugs: 7 Illicit Drugs Marijuana, Cocaine, Opiates (Heroin), Methamphetamine, Ecstasy, Amphetamine, Phencyclidine (PCP) 5 Prescription Drugs Tricyclic Antidepressants, Barbiturates, Benzodiazepines, Methadone, Oxycodone
CONFIRM BIOSCIENCES, INC.
03-5202
In Commercial Distribution

  • 00895330002288 ()


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

DrugConfirm™ Single Panel Marijuana Testing Kit - 00895330002264

DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which is easy to perform from the privacy of your home to detect marijuana usage.
CONFIRM BIOSCIENCES, INC.
03-5601
In Commercial Distribution

  • 00895330002264 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - 00840487101513

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
20-006-001
Not in Commercial Distribution

20-006-001

  • Multiple coagulation factor IVD, kit, clotting

Joimax® Intracs® EM Panel PC - 04250337116547

No Description
Joimax GmbH
JINTPC1105
In Commercial Distribution

  • 04250337116547 ()


  • Electromagnetic surgical navigation device tracking system

BD Vaginal Panel on BD COR System - 00382904439767

Kit Vaginal Reagent COR IVD
BECTON, DICKINSON AND COMPANY
443976
In Commercial Distribution

  • 00382904439767 ()
443976

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

PTS Panels® Lipid Panel Test Strips - 00381931710016

PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to monitor total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA or Plus analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
1710
In Commercial Distribution

  • 00381931710016 ()
  • 10381931710013 ()
1710

  • Multiple lipid analyte IVD, kit, spectrophotometry

Enterovirus Panel Antigen Control Slide, 4 wells - B110QEP66040

No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control

Standard Panel for Aktina IGRT Table Top - B365112150

No Description
Aktina Corp.
11-215
In Commercial Distribution

  • B365112150 ()


  • Indexed-immobilization patient positioning system

BIOFIRE® FILMARRAY® Tropical Fever Panel - 00815381021007

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
424803
In Commercial Distribution

  • 00815381021007 ()


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

BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel - 00815381020659

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424461
In Commercial Distribution

  • 00815381020659 ()


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

FilmArray® Respiratory Panel 2 plus (RP2plus) - 00815381020307

IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0137
Not in Commercial Distribution

  • 00815381020307 ()
RFIT-ASY-0137

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

FilmArray® Respiratory Panel 2 plus (RP2plus) - 00815381020291

IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0136
Not in Commercial Distribution

  • 00815381020291 ()
RFIT-ASY-0136

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

Power Elevating/Articulating Calf Panel (Upper Assy) - 07540147002459

Maxx Power Elevating/Articulating Calf Panel (Upper) Assembly. Optional Elevating Calf Panel (includes foam pad), may be used on its own, or in combination with the Power Down Foot Platform. Assembly includes actuator motor. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0229-PEACP
In Commercial Distribution

  • 07540147002459 ()
PEACP

  • Wheelchair footrest/legrest

Power Elevating Calf Panel Assy- Latitude Style - 07540147002442

Power Elevating Calf Panel Assy with optional Latitude Foot Platform. Optional Elevating Calf Panel Assy is available with or without a foot platform. (Optional Foot Platform Foam Pad available in Onyx (faux vinyl fabric), or standard polyester fabric. Assembly includes actuator motor. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0229-PECP
In Commercial Distribution

  • 07540147002442 ()
PECP

  • Wheelchair footrest/legrest

WALLMOUNT FOR FLAT PANEL MONITOR,

No Description
GLOBAL SURGICAL CORPORATION
M 547FSWMB
In Commercial Distribution

  • 00810040251023 ()


  • General-purpose surgical microscope

Coulmed - 10810087353046

Conductive Body & Leg Restraint Strap, Has 5"Wide Panel Attached to a 2"Wide Strap with 2 Airplane Style Buckles, 0.5" Thick Pressure Relief Padding Sewn onto Center Panel, Without Side Rail Hooks, Adjustable to 96"
Coulmed Products Group LLC
153-1WOH-PR
In Commercial Distribution

  • 10810087353046 ()
153-1WOH-PR

  • Limb/torso/head restraint, reusable

Acuitas - 10812125010010

Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.
Opgen, Inc.
CP3230
Not in Commercial Distribution

  • 10812125010010 ()
CP3230

  • Microplate IVD

Acuitas - 00812125010013

Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.
Opgen, Inc.
CP3230
Not in Commercial Distribution

  • 00812125010013 ()
CP3230

  • Microplate IVD

DrugSmart Cup 10 - 00850019007459

DrugSmart Cup 10, AMP/BAR/BZO/COC150/MDMA/MET500/OPI300/OXY/PCP/THC+ Adulterant Panel, 25tests/kit
CHEMTRON BIOTECH INC
61093D-3C
In Commercial Distribution

  • 00850019007459 ()


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

Healgen (Private Label) - 6114 - 00856464008393

Healgen (DrugConfirm) - 11 Panel Cup Test: AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6114
In Commercial Distribution

  • 00856464008393 ()


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

Status ASSURE - 00868348000249

AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup
Lifesign L.L.C.
76025AA2K
In Commercial Distribution

  • 00868348000249 ()
76025AA2K

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

U-Screen - 00858998006029

UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCup-10MMO300
Not in Commercial Distribution

  • 00858998006029 ()
USSCup-10MMO300UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR

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

HarmonyAIR - 00724995203382

The Single Flat Panel Monitor Yoke Assembly is used with the HarmonyAIR A and E-Series Suspension Systems.
STERIS CORPORATION
E-Series Suspension System
In Commercial Distribution

  • 00724995203382 ()
LES0023

  • Medical monitor/light mount

HarmonyAIR - 00724995203238

The HarmonyAIR E-Series Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Lighting System
Not in Commercial Distribution

  • 00724995203238 ()
LES14

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

HarmonyAIR - 00724995203207

HarmonyAIR A-Series Dual Flat Panel Monitor Arm, 51-inch Arm is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995203207 ()
LAS31

  • Medical monitor/light mount

HarmonyAIR - 00724995203191

HarmonyAIR E-Series Dual Flat Panel Monitor Arm, 51-inch Arm is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995203191 ()
LES31

  • Medical monitor/light mount

HarmonyAIR - 00724995203085

HarmonyAIR A-Series Dual Adjustable Light, Single Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203085 ()
LAS02A

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

HarmonyAIR - 00724995201210

The A-Series 51-inch Auxiliary Arm Dual Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995201210 ()
LAS0090

  • Medical monitor/light mount

HarmonyAIR - 00724995207403

The HarmonyAIR G-Series Spring, Dual Flat Panel Monitor G2 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995207403 ()
LG000005V

  • Medical monitor/light mount

Areta Multi-Drug Test Cup (100 tests kit) - 00855944007529

Areta 6 Panel Drug Test Cup (100 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007529 ()
  • 30855944007520 ()
ACDOA-264-100

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

Areta Multi-Drug Test Cup (50 tests kit) - 00855944007512

Areta 6 Panel Drug Test Cup (50 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007512 ()
  • 30855944007513 ()
ACDOA-264-50

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

Areta Multi-Drug Test Cup (25 tests kit) - 00855944007505

Areta 6 Panel Drug Test Cup (25 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007505 ()
  • 30855944007506 ()
  • 10855944007502 ()
ACDOA-264-25

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

Areta Multi-Drug Test Cup (10 tests kit) - 00855944007499

Areta 6 Panel Drug Test Cup (10 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007499 ()
  • 30855944007490 ()
ACDOA-264-10

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

Areta Multi-Drug Test Cup (5 tests kit) - 00855944007253

Areta 6 Panel Drug Test Cup (5 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007253 ()
  • 30855944007254 ()
ACDOA-264-5

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

MD DrugScreen - 00860146001596

CLIA Waived 8 Panel Cup w/6-AD (THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GLUT-CRE/OXI-SG-PH)
Medical Disposables Corp
MDC-585-AD
In Commercial Distribution

  • 00860146001596 ()


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

MD DrugScreen - 00860113002014

CLIA Waived 8 Panel Cup w/6-AD (THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GLUT-CRE/OXI-SG-PH)
Medical Disposables Corp
MDC-585-AD
In Commercial Distribution

  • 00860113002014 ()


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

MD DrugScreen - 00860113002007

CLIA Waived 8 Panel Cup w/6-AD (THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GLUT-CRE/OXI-SG-PH)
Medical Disposables Corp
MDC-585-AD
In Commercial Distribution

  • 00860113002007 ()


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

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - 00851458005259

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit
BIOFIRE DEFENSE, LLC
DFA2-ASY-0006
In Commercial Distribution

  • 00851458005259 ()
DFA2-ASY-0006

  • Multiple-type tropical pathogen nucleic acid IVD, control

HarmonyAIR - 00724995190279

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

  • 00724995190279 ()
LAS000004

  • Medical monitor/light mount

HarmonyAIR - 00724995190262

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

  • 00724995190262 ()
LAS000003

  • Medical monitor/light mount

HarmonyAIR - 00724995190248

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

  • 00724995190248 ()
LAS000001

  • Medical monitor/light mount

HarmonyAIR - 00724995190156

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

  • 00724995190156 ()
LAH000003

  • Medical monitor/light mount

HarmonyAIR - 00724995190071

The A-Series 59-Inch Auxiliary Arm Dual Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190071 ()
LAS0076

  • Medical monitor/light mount

HarmonyAIR - 00724995170608

The HarmonyAIR E-Series Touch Panel Control Unit with Integrated Power Supplies is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170608 ()
LES0010

  • Medical monitor/light mount

HarmonyAIR - 00724995170578

The Dual Flat Panel Monitor Yoke Assembly is used with the HarmonyAIR A and E-Series Suspension Systems.
STERIS CORPORATION
E-Series Suspension System
In Commercial Distribution

  • 00724995170578 ()
LES0003

  • Medical monitor/light mount

HarmonyAIR - 00724995167431

The Single Flat Panel Monitor Spring Arm 10089779 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995167431 ()
LG000001

  • Medical monitor/light mount

Rapid Response - 00722066005088

One Step 10 Panel DOA Cup (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
BTNX Inc
D10.32-1V
In Commercial Distribution

  • 00722066005088 ()


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

Rapid Response - 00722066004913

10 Panel One Step DOA Cup(10.3.1) - COC150 AMP500 MET500 THC50 MOP2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3.1-1V
In Commercial Distribution

  • 00722066004913 ()


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

Rapid Response - 00722066004890

One Step 10 Panel DOA Cup (10.14.1) - COC150 AMP500 MET500 THC50 MTD300 MOP2000 OXY100 PCP25 BAR300 BZO300
BTNX Inc
D10.14.1-1V
In Commercial Distribution

  • 00722066004890 ()


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