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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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Calibration Gas for in vitro use on Siemens Healthcare Diagnostics Blood Gas analyzers and systems
Siemens Healthcare Diagnostics Inc.
10311037
In Commercial Distribution

  • 00630414112961 ()
477434000

  • Multiple blood gas analyte IVD, calibrator
Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311032
In Commercial Distribution

  • 00630414112350 ()
  • 00630414009278 ()
476379

  • Lactate electrode IVD
In vitro diagnostics medical device. For measurement of glucose in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10320748
In Commercial Distribution

  • 00630414112343 ()
  • 00630414009469 ()
476378

  • Laboratory pH electrode
Test/Blank sensor. An invitro diagnostics device to replace the pH/Na+ sensor on RapidLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311030
In Commercial Distribution

  • 00630414112275 ()
476281

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ Chloride Biosensor for use on the RapidLab® 348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10330133
In Commercial Distribution

  • 00630414112251 ()
  • 00630414010151 ()
476279

  • Chloride (Cl-) electrode IVD
RAPIDLyte Multicap blood collection capillary tubes (500 tubes) approx. volume 175µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10315378
In Commercial Distribution

  • 00630414108490 ()
  • 00630414009421 ()
473764

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLyte Multicap blood collection capillary tubes (50 tubes) approx. volume 175µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10325868
In Commercial Distribution

  • 00630414108476 ()
  • 00630414009575 ()
473763

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLyte Multicap Capillaries (500 tubes) approx. volume 140µL. Each tube contains 130-200 I.U./mL Na+/Li+/Ca++ heparin, titrated with KCl. For capillary blood collection for the analysis of pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10311005
In Commercial Distribution

  • 00630414107622 ()
  • 00630414009261 ()
473646

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLab® 248 Wash Reagent for in vitro diagnostics use with the RAPIDLab® 248 analyzers.
Siemens Healthcare Diagnostics Inc.
10310997
In Commercial Distribution

  • 00630414106564 ()
  • 00630414010052 ()
473497

  • Wash/cleaning solution IVD, automated/semi-automated system
RAPIDLab® 248 6.8/7.3 Calibration buffer reagent is an in vitro diagnostics medical device for use with the RAPIDLab® 248 Blood gas analyzer.
Siemens Healthcare Diagnostics Inc.
10310996
In Commercial Distribution

  • 00630414106540 ()
473496

  • Multiple blood gas analyte IVD, calibrator
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