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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The HarmonyAIR E-Series Spindle Single Light 35.5-inch Dual Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170974 ()
LEH000017

  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Single Light 43-inch Dual Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170967 ()
LEH000016

  • Medical monitor/light mount
The Dual Spindle Single Flat Panel Monitor Light Head 11008900 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170417 ()
LG00028

  • Medical monitor/light mount
25 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007413 ()
  • 30855944007414 ()
  • 10855944007410 ()
EDOAP-295-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007406 ()
  • 30855944007407 ()
EDOAP-295-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007390 ()
  • 30855944007391 ()
EDOAP-295-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007383 ()
  • 30855944007384 ()
EDOAP-295-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
Six Panel Clear Scan Drug Test Cup with Adulterants Drug Combo AMP/BZO/COC/MET/OPI/THC with Adulterants
MERGERS MARKETING, INC.
CSC-264AD
In Commercial Distribution

  • 00851000007328 ()
  • 00851000007335 ()
  • 10851000007332 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 8 Panel, CLIA Waived, AMP, BUP, BZO, COC, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-285T
In Commercial Distribution

  • 00850798007626 ()
  • 00850798007619 ()
  • 00850798007602 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit
BIOFIRE DEFENSE, LLC
DFA2-ASY-0019
In Commercial Distribution

  • 00851458005280 ()
DFA2-ASY-0019

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
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 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 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
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

  • 00860003196939 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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
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
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
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
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
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 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 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
Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR DOA13A
In Commercial Distribution

  • 20850011007130 ()
  • 10850011007133 ()
  • 00850011007136 ()
TNR DOA13A

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA7125
In Commercial Distribution

  • 00850011007082 ()
  • 10850011007089 ()
  • 20850011007086 ()
TNR CDOA7125

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
MERCEDES MEDICAL, LLC
TNR CDOA6125
In Commercial Distribution

  • 00850011007068 ()
  • 10850011007065 ()
  • 20850011007062 ()
TNR CDOA6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56519
In Commercial Distribution

  • 10190302019057 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
963608
In Commercial Distribution

  • 10190302019040 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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