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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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)
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)
No Description
Aktina Corp.
11-215
In Commercial Distribution

  • B365112150 ()


  • Indexed-immobilization patient positioning system
No Description
GLOBAL SURGICAL CORPORATION
M 547FSWMB
In Commercial Distribution

  • 00810040251023 ()


  • General-purpose surgical microscope
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 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
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
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
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
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
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
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) 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
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
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
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
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
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
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
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
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