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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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Reference Electrode Refill. An in vitro diagnostic device for use on the RAPIDLab® 248/348/348EX.
Siemens Healthcare Diagnostics Inc.
10320458
In Commercial Distribution

  • 00630414114934 ()
478498

  • Ion selective electrode (ISE) reference solution IVD, reagent
The blood gas Proficiency Pre-Test is a pre-proficiency test material supplied three times a year for verifying performance of pH/blood gas, electrolyte, metabolite and CO-oximetry analyzers.
Siemens Healthcare Diagnostics Inc.
10340375
In Commercial Distribution

  • 00630414112985 ()
477440000

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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
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