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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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Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 248/348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10323084
In Commercial Distribution

  • 00630414112206 ()
476273

  • Ion selective electrode (ISE) reference solution IVD, reagent
Ready Sensor™ Potassium Biosensor. An in vitro diagnostic device for use on the RapidLab® 348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10327404
In Commercial Distribution

  • 00630414112183 ()
  • 00630414010496 ()
476270

  • Potassium (K+) electrode IVD
Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10315922
In Commercial Distribution

  • 00630414112169 ()
  • 00630414010144 ()
476268

  • Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ pH Biosensor for use on the RapidLab® 248/348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10312556
In Commercial Distribution

  • 00630414112145 ()
  • 00630414010106 ()
476267

  • Blood pH electrode
Ready Sensor™ Sodium Biosensor for use on the RapidLab® 348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10312557
In Commercial Distribution

  • 00630414112121 ()
  • 00630414010113 ()
476266

  • Sodium (Na+) electrode IVD
Ready Sensor™ Gold pCO2 Biosensor for use on the RapidLab® 348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10317498
In Commercial Distribution

  • 00630414112107 ()
476247

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ pO2 Biosensor for use on the RapidLab® 248/348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10324408
In Commercial Distribution

  • 00630414112077 ()
476246

  • Blood oxygen electrode IVD
RAPIDLyte Multicap blood collection capillary tubes (100 tubes) approx. volume 60µL. 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.
10314213
In Commercial Distribution

  • 00630414108766 ()
  • 00630414009414 ()
473823

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLab® 348/348EX Wash Reagent for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.
Siemens Healthcare Diagnostics Inc.
10309756
In Commercial Distribution

  • 00630414053448 ()
  • 00630414010021 ()
104226

  • Wash/cleaning solution IVD, automated/semi-automated system
Xprecia™ System PT/INR Strips, is intended for use by professional healthcare providers to provide an INR (International NormalizedRatio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin
Siemens Healthcare Diagnostics Inc.
11065645
In Commercial Distribution

  • 00630414034348 ()
  • 00630414188690 ()
11065645

  • Prothrombin time (PT) IVD, reagent
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