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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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ADVIA Centaur® Systems, ACS:180® Systems VANC Calibrator - 00630414121444

Vancomycin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311377
Not in Commercial Distribution

  • 00630414121444 ()
570061

  • Vancomycin therapeutic drug monitoring IVD, calibrator

Ready Sensor™ Glucose Biosensor - 00630414121154

Ready Sensor™ Glucose Biosensor for use on the Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Glucose WarrantyReaplacement
Siemens Healthcare Diagnostics Inc.
10312818
In Commercial Distribution

  • 00630414121154 ()
570024

  • Glucose IVD, kit, ion-selective electrode (ISE)

RAPIDQC® Plus Level 3 - 00630414118444

For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10325104
In Commercial Distribution

  • 00630414118444 ()
  • 00630414009568 ()
478943000

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

RAPIDQC® Plus Level 2 - 00630414118413

For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10341140
In Commercial Distribution

  • 00630414118413 ()
  • 00630414009742 ()
478942000

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

RAPIDQC® Plus Level 1 - 00630414118383

For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10323692
In Commercial Distribution

  • 00630414118383 ()
  • 00630414009537 ()
478941000

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

RAPIDLab® Reference Electrode Fill - 00630414117539

RAPIDLab® series Reference Electrode Fill Solution. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311081
In Commercial Distribution

  • 00630414117539 ()
  • 00630414010090 ()
478822

  • Ion selective electrode (ISE) reference solution IVD, reagent

Adapters - 00630414116297

100 Adaptors for an In vitro diagnostics device. For use with Siemens Healthcare Diagnostics blood collection capillary tubes and analyzers.
Siemens Healthcare Diagnostics Inc.
10330785
In Commercial Distribution

  • 00630414116297 ()
  • 00630414010168 ()
478647

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

Blood Gas blood collection capillary tubes - 00630414115856

500 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 140µL)
Siemens Healthcare Diagnostics Inc.
10327012
In Commercial Distribution

  • 00630414115856 ()
  • 00630414009599 ()
478608

  • Capillary blood collection tube IVD, lithium heparin

Capillary Caps - 00630414115801

100 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics Multicap® and Multicap-S 2.34mm OD blood collection capillary tubes.
Siemens Healthcare Diagnostics Inc.
10311054
In Commercial Distribution

  • 00630414115801 ()
  • 00630414009292 ()
478605

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

Blood Gas blood collection capillary tubes - 00630414115788

50 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 140µL)
Siemens Healthcare Diagnostics Inc.
10327283
In Commercial Distribution

  • 00630414115788 ()
  • 00630414009605 ()
478604

  • Capillary blood collection tube IVD, lithium heparin

Capillary Caps - 00630414115764

200 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics. 1.65mm OD Glass blood collection capillary tubes.
Siemens Healthcare Diagnostics Inc.
10311053
In Commercial Distribution

  • 00630414115764 ()
  • 00630414009285 ()
478601

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

Blood Gas blood collection capillary tubes - 00630414115740

100 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 100µL)
Siemens Healthcare Diagnostics Inc.
10321712
In Commercial Distribution

  • 00630414115740 ()
  • 00630414009490 ()
478600

  • Capillary blood collection tube IVD, lithium heparin

RAPIDLab® pH Electrode Fill - 00630414115269

pH Electrode Fill Solution (Pack of 3). An In vitro diagnostic medical device for use on RAPIDLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311046
In Commercial Distribution

  • 00630414115269 ()
  • 00630414010069 ()
478533

  • Hydrogen (H+)/pH electrode IVD

Capillary Caps - 00630414115238

Multicap® and Multicap-S 2.34mm OD blood collection capillary tubes
Siemens Healthcare Diagnostics Inc.
10328655
In Commercial Distribution

  • 00630414115238 ()
  • 00630414010502 ()
478527

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

Ready Sensor™ GOLD Reference Sensor Inner Element - 00630414115030

Ready Sensor™ GOLD Replacement reference Sensor Inner Element. An in vitro diagnostics device.
Siemens Healthcare Diagnostics Inc.
10329947
In Commercial Distribution

  • 00630414115030 ()
478509

  • Ion selective electrode (ISE) reference solution IVD, reagent

Ready Sensor™ GOLD Reference Sensor Refill - 00630414114934

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

Proficiency Pre-Test - 00630414112985

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 - 00630414112978

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

Cal Gas - 00630414112961

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 - 00630414112350

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

Ready Sensor™ Glucose Biosensor - 00630414112343

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

TB2 pH/Na+ Test/Blank Sensor - 00630414112275

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™ GOLD Chloride Sensor - 00630414112251

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™ GOLD Reference Sensor - 00630414112206

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™ GOLD Potassium Sensor - 00630414112183

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™ GOLD Calcium Sensor - 00630414112169

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™ GOLD pH Sensor - 00630414112145

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™ GOLD Sodium Sensor - 00630414112121

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 Sensor - 00630414112107

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™ GOLD pO2 Sensor - 00630414112077

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

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414108766

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

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414108490

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

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414108476

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

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414107622

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 - 00630414106564

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 Buffer - 00630414106540

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

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414105994

50 blood collection capillary tubes (approx. volume 140µL). For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb
Siemens Healthcare Diagnostics Inc.
10314796
In Commercial Distribution

  • 00630414105994 ()
  • 00630414010120 ()
473193

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

Capillaries pH/Blood Gas/Na+/K+ - 00630414099231

100 blood collection capillary tubes (approx. volume 100uL) Each tube contains 130-200 I.U./mL lithium heparin titrated with Na+/K+. For capillary blood collection for the analysis of pH/Blood Gas and Na+/K+ by ISE analyzer
Siemens Healthcare Diagnostics Inc.
10310990
In Commercial Distribution

  • 00630414099231 ()
  • 00630414009247 ()
471836

  • Capillary blood collection tube IVD, lithium heparin

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414058320

RAPIDLyte Multicap blood collection capillary tubes (500 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10322912
In Commercial Distribution

  • 00630414058320 ()
  • 00630414009506 ()
108758

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

ADVIA Centaur® LH2 MCM - 00630414057361

LH 2 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309794
In Commercial Distribution

  • 00630414057361 ()
106794

  • Luteinizing hormone (LH) IVD, control
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