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
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
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
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
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
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
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
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 4 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-401
Not in Commercial Distribution

  • 10849771037818 ()
  • 00849771037811 ()
  • 00849771044154 ()
SL401

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-204
Not in Commercial Distribution

  • 00849771033509 ()
  • 00849771033493 ()
  • 00849771044093 ()
SL204

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-202
Not in Commercial Distribution

  • 00849771033486 ()
  • 00849771033479 ()
  • 00849771044079 ()
SL202

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-201
Not in Commercial Distribution

  • 10849771033469 ()
  • 00849771033462 ()
  • 00849771044062 ()
SL201

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-211
Not in Commercial Distribution

  • 00849771033264 ()
  • 00849771033257 ()
  • 00849771044147 ()
SL211

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-203
Not in Commercial Distribution

  • 00849771032939 ()
  • 00849771032922 ()
  • 00849771044086 ()
SL203

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-207
Not in Commercial Distribution

  • 10849771032738 ()
  • 00849771032731 ()
  • 00849771044109 ()
SL207

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-210
Not in Commercial Distribution

  • 00849771033127 ()
  • 00849771032144 ()
  • 00849771044130 ()
SL210

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-209
Not in Commercial Distribution

  • 10849771031106 ()
  • 00849771031109 ()
  • 00849771044123 ()
SL209

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-208
Not in Commercial Distribution

  • 00849771033516 ()
  • 00849771025696 ()
  • 00849771044116 ()
SL208

  • Procedural medication labelling set
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 (DrugConfirm) - 10 Panel Dip Card - CLIA - AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-3104
In Commercial Distribution

  • 00895330002776 ()


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