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
Slope Gas for in vitro use on Siemens Healthcare Diagnostics Blood Gas analyzers and systems
Siemens Healthcare Diagnostics Inc.
10311038
In Commercial Distribution

  • 00630414112978 ()
477438000

  • Multiple blood gas analyte IVD, calibrator
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
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
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
Ready Sensor™ Hct Biosensor for in vitro use on the RapidLab® 348/348ex pH/Blood Gas Analyzers.
Siemens Healthcare Diagnostics Inc.
10309783
In Commercial Distribution

  • 00630414056296 ()
106042

  • Multiple blood gas analyte IVD, calibrator
CK-MB 2 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309782
In Commercial Distribution

  • 00630414056098 ()
105805

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, control
RAPIDLab® 348/348EX HCT Slope for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.
Siemens Healthcare Diagnostics Inc.
10309776
In Commercial Distribution

  • 00630414055930 ()
  • 00630414010045 ()
105670

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
RAPIDLab® Deproteinizer for in vitro diagnostics use with the RAPIDLab® series analyzers (Pack 10)
Siemens Healthcare Diagnostics Inc.
10309775
In Commercial Distribution

  • 00630414055909 ()
  • 00630414010038 ()
105610

  • Wash/cleaning solution IVD, automated/semi-automated system
For in vitro diagnostics use for calibration of the RapidLab® 348/348ex pH/Blood Gas Analyzers
Siemens Healthcare Diagnostics Inc.
10309768
In Commercial Distribution

  • 00630414055657 ()
105070

  • Multiple blood gas analyte IVD, calibrator
Vitamin B12 - Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309760
In Commercial Distribution

  • 00630414054124 ()
104523

  • Vitamin B12 IVD, control
RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent
Siemens Healthcare Diagnostics Inc.
10309757
In Commercial Distribution

  • 00630414053455 ()
104227

  • Multiple blood gas analyte IVD, calibrator
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
Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Lactate Warranty Replacement
Siemens Healthcare Diagnostics Inc.
10334138
In Commercial Distribution

  • 00630414051499 ()
102455

  • Lactate electrode IVD
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
Emit II Plus Specialty Multi Drug Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10720807
In Commercial Distribution

  • 00630414028026 ()
9T529UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720808
In Commercial Distribution

  • 00630414028019 ()
9T039UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Emit II Plus Oxycodone Negative Control 100
Siemens Healthcare Diagnostics Inc.
10720809
In Commercial Distribution

  • 00630414028002 ()
9T609UL

  • Oxycodone IVD, control
Emit II Plus Oxycodone Positive Control 100
Siemens Healthcare Diagnostics Inc.
10720810
In Commercial Distribution

  • 00630414027999 ()
9T619UL

  • Oxycodone IVD, control
Emit II Plus Oxycodone Negative Control 300
Siemens Healthcare Diagnostics Inc.
10720811
In Commercial Distribution

  • 00630414027982 ()
9T709UL

  • Oxycodone IVD, control
Emit II Plus Oxycodone Positive Control 300
Siemens Healthcare Diagnostics Inc.
10720812
In Commercial Distribution

  • 00630414027975 ()
9T719UL

  • Oxycodone IVD, control
Emit II Plus Specialty Multi Drug Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10720813
In Commercial Distribution

  • 00630414027968 ()
9T549UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Specialty Multi Drug Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10720814
In Commercial Distribution

  • 00630414027951 ()
9T569UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Specialty Multi Drug Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10720815
In Commercial Distribution

  • 00630414027944 ()
9T589UL

  • Multiple drugs of abuse IVD, calibrator
Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720816
In Commercial Distribution

  • 00630414027937 ()
9T029UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
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