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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mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC002.10.0001EI
In Commercial Distribution

  • G474MC002100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Inspiration Ventilator System, model 7i with 12" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000102US0 ()
F7300000-7i-S-US

  • General-purpose intensive-care ventilator
Inspiration Ventilator System, model 7i with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000101US0 ()
F7300000-7i-L-US

  • General-purpose intensive-care ventilator
Trumpf Medical/Medizin Operating panel for table top II
Baxter Medical Systems GmbH + Co. KG
1549939
Not in Commercial Distribution

  • 00887761988484 ()


  • Operating room equipment remote control
FIXED ARM SIDEFRAME & SIDE PANEL - LEFT - TRAVELER SE PLUS
GF HEALTH PRODUCTS, INC.
90763002A
In Commercial Distribution

  • M36890763002A1 ()
90763002A

  • Push-rim manual wheelchair, non-bariatric
FIXED ARM SIDEFRAME & SIDE PANEL - RIGHT - TRAVELER SE PLUS
GF HEALTH PRODUCTS, INC.
90763001A
In Commercial Distribution

  • M36890763001A1 ()
90763001A

  • Push-rim manual wheelchair, non-bariatric
Sample Collection Kit, Blood (5 DBS), Food Sensitivity Panel
Cue Health Inc.
C2234
In Commercial Distribution

  • 00810040821103 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Dual), Women's Fertility Panel
Cue Health Inc.
C2227
In Commercial Distribution

  • 00810040821066 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Dual), Women's Health Panel
Cue Health Inc.
C2226
In Commercial Distribution

  • 00810040821059 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Men's Health Panel
Cue Health Inc.
C2245
In Commercial Distribution

  • 00810040821011 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Heart Health Panel
Cue Health Inc.
C2224
In Commercial Distribution

  • 00810040820984 ()


  • Capillary blood collection kit IVD
OEC Elite MiniView C-Arm Drape – 13 cm Flat Panel
EXACT MEDICAL MANUFACTURING, INC.
E6066
In Commercial Distribution

  • 26975424196210 ()
  • 06975424196216 ()
E6066

  • Medical equipment/instrument drape, single-use
The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1836 SE E
In Commercial Distribution

  • 04547410483420 ()

  • 460x850x15mm


  • Stationary basic diagnostic x-ray system, digital
POS and NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini
Mmqci
v.00
In Commercial Distribution

  • 00852720008145 ()
M425

  • Multiple-genus respiratory virus nucleic acid IVD, control
SureSmile Dr Starter Kit
DENTSPLY SIRONA ORTHODONTICS INC.
ORX00001
Not in Commercial Distribution

  • D746ORX000010 ()
  • D746ORX000011 ()
ORX00001

  • Dental abrasive strip, reusable
  • Dental delivery system instrument unit, pneumatic
The Single Flat Panel Monitor, Light Head with Video, Single Flat Panel Monitor-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166731 ()
LGH00037

  • Medical monitor/light mount
CT thyroid shield
F&L Medical Products LLC
Standard
In Commercial Distribution

  • 00860010574591 ()


  • Radiation shielding panel, portable/mobile
  • Radiation shielding collar
CT eye shield
F&L Medical Products LLC
Standard
In Commercial Distribution

  • 00860010574584 ()


  • Radiation shielding panel, portable/mobile
  • Radiation shielding collar
CT breast shield large
F&L Medical Products LLC
Large
In Commercial Distribution

  • 00860010574577 ()


  • Radiation shielding apron
  • Radiation shielding panel, portable/mobile
CT Breast shield medium
F&L Medical Products LLC
Medium
In Commercial Distribution

  • 00860010574560 ()


  • Radiation shielding apron
  • Radiation shielding panel, portable/mobile
Single Panel Pre Screen Plus Dip Card Drug Combo: THC
MERGERS MARKETING, INC.
PS-THC-114
In Commercial Distribution

  • 10850557007413 ()
  • 00850557007409 ()
  • 00850557007416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: BUP
MERGERS MARKETING, INC.
PS-BUP-114
In Commercial Distribution

  • 00850557007003 ()
  • 00850557007010 ()
  • 10850557007017 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3B Medical, Inc. filter replacements for cabinent and panel filters
3B MEDICAL, INC.
CIR1020 CIR1030
In Commercial Distribution

  • 00853041003819 ()


  • Stationary oxygen concentrator
LED Body Panel- Boost Branded- (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN19I
In Commercial Distribution

  • 05060534510364 ()
145A

  • Cosmetic red-light phototherapy system, home-use
ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch
GENMARK DIAGNOSTICS, INC.
BCID-GP Cartridge Pouch
In Commercial Distribution

  • 00857167005337 ()
KT021791

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box
GENMARK DIAGNOSTICS, INC.
BCID-GP 12 Kit Box
In Commercial Distribution

  • 00857167005320 ()
EA003012

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
UScreen™ RAPID DRUG TEST CUP, 14 Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-14CLIA
In Commercial Distribution

  • 30850054867941 ()
  • 00850054867940 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone 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
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: OXY
MERGERS MARKETING, INC.
PS-OXY
In Commercial Distribution

  • 00851000007274 ()
  • 00851000007267 ()
  • 00851000007250 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: ETG
MERGERS MARKETING, INC.
PS-ETG
In Commercial Distribution

  • 10851000007097 ()
  • 00851000007090 ()
  • 00851000007083 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2186G
In Commercial Distribution

  • D0692186G0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2186C
In Commercial Distribution

  • D0692186C0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2184G
In Commercial Distribution

  • D0692184G0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2184C
In Commercial Distribution

  • D0692184C0 ()


  • Dental delivery system
3 Panel One Step DOA Cup(3.36) - COC300 AMP1000 MET1000
BTNX Inc
D3.36-1V
In Commercial Distribution

  • 00722066005309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MassCheck® Steroid Panel 1&2, Serum Control Level III
Chromsystems Instruments + Chemicals GmbH
0340
In Commercial Distribution

  • 04250317539823 ()
  • 04250317546708 ()

  • 5 x 3ml
0340

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1&2, Serum Control Level II
Chromsystems Instruments + Chemicals GmbH
0339
In Commercial Distribution

  • 04250317539816 ()
  • 04250317546692 ()

  • 5 x 3ml
0339

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1&2, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0338
In Commercial Distribution

  • 04250317539809 ()
  • 04250317546685 ()

  • 5 x 3ml
0338

  • Multiple steroid hormone IVD, control
accutest MultiDrug Screen- 5 panel (AMP/COC/MET/THC/OPI)
JANT PHARMACAL CORPORATION
DS01AC425
In Commercial Distribution

  • 10763924001429 ()
  • 00763924001422 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Sony Medical Grade Flat Panel Monitor, HD, without stand, 24"
BR Surgical, LLC
BR900-4424
In Commercial Distribution

  • 00840183514006 ()
BR900-4424

  • Image display unit, colour
4 Panel Home Drug Test Kit THC COC OPI MET
CONFIRM BIOSCIENCES, INC.
RO-DRC004
In Commercial Distribution

  • 00895330002370 ()


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