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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 - 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 - 00724995171124

The HarmonyAIR E-Series Spindle Single Light 43IN Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171124 ()
LES000016

  • 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 - 00724995169626

The Single Spindle Single Flat Panel Monitor 11008897 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995169626 ()
LGH00041

  • Medical monitor/light mount

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

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

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

Five Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007447

Five Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-254AD
In Commercial Distribution

  • 00850557007447 ()
  • 00850557007454 ()
  • 10850557007451 ()


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

Seven Panel PreScreen Plus Dip Card (CLIA Waived) - 00850557007188

Seven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-274
In Commercial Distribution

  • 00850557007188 ()
  • 00850557007195 ()
  • 10850557007192 ()


  • 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

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

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

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

Verify - G474MV002090004EI0

mLife Verify 9 Panel Oral Fluid Drug Test AMP BAR BZO COC MDMA MET MTD OPI OXY
Mlife Diagnostics, LLC
MV002.09.0004EI
In Commercial Distribution

  • G474MV002090004EI0 ()


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

UCP Home Drug Screening Test Cups - 10817038021580

UCP Home Drug Screening Test Cups 5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
UCP BIOSCIENCES, INC.
U-CUP-1254-RCN
In Commercial Distribution

  • 20817038021587 ()
  • 10817038021580 ()
  • 00817038021583 ()
U-CUP-1254-RCN

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