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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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
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
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
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
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 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 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 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
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
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 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 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 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 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 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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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
10 Panel One Step DOA Cup(10.3) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3-1V
In Commercial Distribution

  • 00722066004586 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The G5 Dual Camera Ready-Single Flat Panel Monitor-Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167295 ()
LGH42N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Single Flat Panel Monitor, Light Head G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166700 ()
LG00026

  • Medical monitor/light mount
The Single Flat Panel Monitor, Light Head Spindle-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166649 ()
LG00023

  • Medical monitor/light mount
The Air Single M7 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

  • 00724995166045 ()
LM09N

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