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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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Dimension® CHEM I CAL - 00630414948492

Chemistry I Calibrator, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10716280
In Commercial Distribution

  • 00630414948492 ()
DC18C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Flex® reagent cartridge AMM - 00630414948102

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711992
In Commercial Distribution

  • 00630414948102 ()
  • 00630414006093 ()
K3119

  • Ammonia IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge AMM - 00630414948096

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711991
In Commercial Distribution

  • 00630414948096 ()
  • 00630414006086 ()
DF119

  • Ammonia IVD, kit, spectrophotometry

Dimension® CHEM III CAL - 00630414948034

Chemistry III Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10711580
In Commercial Distribution

  • 00630414948034 ()
DC130

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CHEM 3 CAL - 00630414948027

Chemistry 3 Calibrator, 6 (3A x 2.5 mL; 3B x 2.5 mL)
Siemens Healthcare Diagnostics Inc.
10711579
In Commercial Distribution

  • 00630414948027 ()
KC130A

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

RAPIDPoint® 500 Measurement Cartridge - 00630414947556

RAPIDPoint® 500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10844813
In Commercial Distribution

  • 00630414947556 ()
10844813

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

RAPIDPoint® 405/500 Measurement Cartridge - 00630414947549

RAPIDPoint® 405/500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10844812
In Commercial Distribution

  • 00630414947549 ()
10844812

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

RAPIDPoint® 405/500 Measurement Cartridge - 00630414947532

RAPIDPoint® 405/500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10844811
In Commercial Distribution

  • 00630414947532 ()
10844811

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

RAPIDPoint® 400 Measurement Cartridge - 00630414947525

RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 analyzer.
Siemens Healthcare Diagnostics Inc.
10844810
In Commercial Distribution

  • 00630414947525 ()
10844810

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

IMMULITE® 1000 Immunoassay System - 00630414947440

IMMULITE® 1000 Instrument, 110 VOLT
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380058
In Commercial Distribution

  • 00630414947440 ()
030006-03

  • Chemiluminescent immunoassay analyser IVD
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