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 Class Implantable

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Two stage gas Pressure Regulator for Siemens Healthcare Diagnostics Blood Gas Systems
Siemens Healthcare Diagnostics Inc.
10310422
In Commercial Distribution

  • 00630414467818 ()
127191

  • Multiple blood gas analyte IVD, calibrator
Insulin Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10310463
In Commercial Distribution

  • 00630414466200 ()
129885

  • Buffered sample diluent IVD
Insulin Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310462
In Commercial Distribution

  • 00630414466187 ()
  • 00630414003375 ()
129883

  • Buffered sample diluent IVD
For in vitro diagnostic use for multi-level quality control of RAPIDPoint 400/500 series and RAPIDLab 1200 series systems.
Siemens Healthcare Diagnostics Inc.
10310323
In Commercial Distribution

  • 00630414465883 ()
120241

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
PCHE - ADVIA Chem. - RGT - 4x133 tests
Siemens Healthcare Diagnostics Inc.
10329639
In Commercial Distribution

  • 00630414465401 ()
B01-4605-01

  • Acetylcholinesterase IVD, kit, spectrophotometry
Total Protein - ADVIA Chem. - RGT - 4x850/4x700 tests
Siemens Healthcare Diagnostics Inc.
10311878
In Commercial Distribution

  • 00630414465227 ()
B01-4601-01

  • Total protein IVD, kit, spectrophotometry
C-Peptide - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310448
In Commercial Distribution

  • 00630414464053 ()
129026

  • C-peptide IVD, kit, chemiluminescent immunoassay
C-Peptide S Master Curve Material Kit - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310446
In Commercial Distribution

  • 00630414464022 ()
129023

  • C-peptide IVD, control
C-Peptide - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10310445
In Commercial Distribution

  • 00630414464008 ()
129021

  • C-peptide IVD, calibrator
CA 15-3 - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10329796
In Commercial Distribution

  • 00630414461359 ()
128538

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
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