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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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FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
5
In Commercial Distribution

  • M68980801050 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
Nova 5/5+ Analyzer w/ Printer
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 10385480539897 ()
  • 00385480539890 ()
53989

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 5 Na+, K+, Cl-, HCt CALIBRATOR
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 00385480156486 ()
15648

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
NOVA 5/5+ Analyzer w/ Printer( No Acc Pack)
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 10385480141564 ()
  • 00385480141567 ()
14156

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
5
Not in Commercial Distribution

  • 04250802900411 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
Cloud based DICOM picture archiving system
Oehm und Rehbein GmbH
5
In Commercial Distribution

  • 04250802900169 ()
OC1000

  • Radiology DICOM image processing application software
No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode
Tinted Glow Powder
JBC and Company
5
In Commercial Distribution

  • D85105 ()
5-2

  • Dental appliance fabrication material, resin
No Description
icometrix NV
5
In Commercial Distribution

  • B621ICOBRAIN50 ()


  • Radiology DICOM image processing application software
No Description
Mobilehelp, LLC
5
In Commercial Distribution

  • 00817644020079 ()


  • Home healthcare information system application software
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