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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5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-154A3
In Commercial Distribution

  • 20816490020411 ()
  • 10816490020414 ()
  • 00816490020417 ()
HDOA-154A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Inspiration Ventilator System, model 7i Flagship with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000103US0 ()
F7300000-7i-F-US

  • General-purpose intensive-care ventilator
QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
MICROBIOLOGICS INC.
ABT-001
In Commercial Distribution

  • 80845357043708 ()
ABT-001

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Control Panel
MICROBIOLOGICS INC.
8209
In Commercial Distribution

  • 70845357041325 ()
8209

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
MICROBIOLOGICS INC.
8208
In Commercial Distribution

  • 70845357041318 ()
8208

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Gram Positive Identification Panel
MICROBIOLOGICS INC.
5248P
In Commercial Distribution

  • 70845357039940 ()
5248P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Gram Negative Identification Panel
MICROBIOLOGICS INC.
5247P
In Commercial Distribution

  • 70845357039933 ()
5247P

  • Multiple bacteria species culture isolate identification control IVD, kit
4 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000
Instant Technologies, Inc.
ABTDOAW14701A
In Commercial Distribution

  • 30817405023319 ()
  • 00817405023318 ()
  • 10817405023315 ()
ABTDOAW14701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET500-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60740-6
In Commercial Distribution

  • B29860740610 ()
60740-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI300-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60613-6
In Commercial Distribution

  • B29860613610 ()
60613-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
31106-6
In Commercial Distribution

  • B2983110660 ()
31106-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET500-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
30908-6
In Commercial Distribution

  • B2983090860 ()
30908-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80701
Not in Commercial Distribution

  • B313OT807011 ()
  • B313OT807010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 12 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC12P
In Commercial Distribution

  • 20612479255337 ()
  • 10612479255323 ()
  • 40612479255348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 10 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC10P
In Commercial Distribution

  • 20612479255306 ()
  • 10612479255293 ()
  • 40612479255317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6125A3
In Commercial Distribution

  • 20816490022484 ()
  • 10816490022487 ()
  • 00816490022480 ()
HDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Mylar Clad Cartridge Tube for Desk, Panel & Wall Unit 33
W. A. BAUM CO., INC.
2300
In Commercial Distribution

  • 00810010923547 ()
2300

  • Aneroid manual sphygmomanometer
The Dual M5 without Control with two Flat Panel Control, with two Flat Panel Monitors is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165741 ()
LM03N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
No Description
PaloDEx Group Oy
eXam5-1
In Commercial Distribution

  • 06430035872503 ()
900467

  • Radiography digital imaging scanner
No Description
PaloDEx Group Oy
GXPS-500
Not in Commercial Distribution

  • 06430035872497 ()
900469

  • Dental computed radiography digital imaging scanner
No Description
PaloDEx Group Oy
DXR60
In Commercial Distribution

  • 06430035872480 ()
900682

  • Radiography digital imaging scanner
No Description
PaloDEx Group Oy
DXR50
In Commercial Distribution

  • 06430035872473 ()
900267

  • Radiography digital imaging scanner
CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
OMEGA MEDICAL IMAGING, LLC
CS-series-FP
In Commercial Distribution

  • 00853901007018 ()


  • Stationary angiographic x-ray system, digital
CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
OMEGA MEDICAL IMAGING, LLC
CS50
In Commercial Distribution

  • 00853901007001 ()


  • Stationary angiographic x-ray system, digital
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.15
In Commercial Distribution

  • 00854344007740 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.14
In Commercial Distribution

  • 00854344007733 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.13
In Commercial Distribution

  • 00854344007726 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.12
In Commercial Distribution

  • 00854344007696 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.10
In Commercial Distribution

  • 00854344007672 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.5.0
In Commercial Distribution

  • 00854344007436 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.2.0
In Commercial Distribution

  • 00854344007405 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v4.0.1
In Commercial Distribution

  • 00854344007290 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v4.0.1
In Commercial Distribution

  • 00854344007283 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.1.0
In Commercial Distribution

  • 00854344007221 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.2
In Commercial Distribution

  • 00854344007184 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR
In Commercial Distribution

  • 00854344007030 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.1
In Commercial Distribution

  • 00854344007016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
AGFA
5520/150
In Commercial Distribution

  • 05414904281321 ()
MBFTK

  • Stationary basic diagnostic x-ray system, digital
No Description
AGFA
1.0.1
In Commercial Distribution

  • 05414904278840 ()
MA45R

  • Radiology DICOM image processing application software
No Description
AGFA
5540/100
In Commercial Distribution

  • 05414904275535 ()
MAVV8

  • Stationary basic diagnostic x-ray system, digital
DR with option for Tomosynthesis
AGFA
5530/100
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, digital
DR 400 5520/200 Automatic
AGFA
5520/200
In Commercial Distribution

  • 05414904217870 ()
58UCJ

  • Stationary basic diagnostic x-ray system, digital
NX 2.0 SOFTWARE
AGFA
2.0.
In Commercial Distribution

  • 05414904217818 ()
E1AMX

  • Radiology DICOM image processing application software
No Description
AGFA
CR MD1.0 GENERAL SET 35X35
In Commercial Distribution

  • 05414904209752 ()

  • Width: 35 Centimeter
  • Length: 35 Centimeter
564S1

  • Digital imaging cassette/phosphor plate
No Description
AGFA
V3.0
In Commercial Distribution

  • 05414904208168 ()
E3M81

  • Radiology DICOM image processing application software
DR 600 SEMI-AUTOMATIC
AGFA
5530/200
In Commercial Distribution

  • 05414904197202 ()
542WK

  • Stationary basic diagnostic x-ray system, digital
DR 600 FULLY AUTOMATIC
AGFA
5530/100
In Commercial Distribution

  • 05414904196298 ()
542VH

  • Stationary basic diagnostic x-ray system, digital
CR HD5.0S GENERAL CASSETTE 18X24 CM
AGFA
CR HD5.0S GENERAL CASSETTE 18X24
In Commercial Distribution

  • 05414904188934 ()

  • Length: 18 Centimeter
  • Width: 24 Centimeter
53L5U

  • Digital imaging cassette
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