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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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For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
DiaSpect Medical GmbH
90B.0013
In Commercial Distribution

  • 04048534001724 ()
  • 04048534001571 ()


  • Total haemoglobin (totHb) IVD, control
For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
DiaSpect Medical GmbH
90B.0012
In Commercial Distribution

  • 04048534001717 ()
  • 04048534001564 ()


  • Total haemoglobin (totHb) IVD, control
For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
DiaSpect Medical GmbH
90B.0011
In Commercial Distribution

  • 04048534001700 ()
  • 04048534001557 ()


  • Total haemoglobin (totHb) IVD, control
For the quantitative determination of hemoglobin in whole blood.
DiaSpect Medical GmbH
90C.0001
In Commercial Distribution

  • 04048534001694 ()
  • 04048534001540 ()
  • 04048534001687 ()


  • Haemoglobin analyser IVD, point-of-care
For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
EKF-diagnostic GmbH
7049-6213
In Commercial Distribution

  • 04048534001991 ()
  • 14048534001998 ()
900-503

  • Total haemoglobin (totHb) IVD, control
For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
EKF-diagnostic GmbH
7049-6212
In Commercial Distribution

  • 04048534001984 ()
  • 14048534001981 ()
900-502

  • Total haemoglobin (totHb) IVD, control
For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
EKF-diagnostic GmbH
7049-6211
In Commercial Distribution

  • 04048534001977 ()
  • 14048534001974 ()
900-501

  • Total haemoglobin (totHb) IVD, control
For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-3013-0369
In Commercial Distribution

  • 24048534001964 ()
  • 14048534001967 ()
  • 04048534001953 ()
900-500

  • Haemoglobin analyser IVD, point-of-care
No Description
Terumo Cardiovascular Systems Corporation
62093
In Commercial Distribution

  • 50699753454045 ()
  • 00699753454040 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Terumo Cardiovascular Systems Corporation
62017
In Commercial Distribution

  • 00699753453975 ()
  • 50699753453970 ()


  • Cardiopulmonary bypass system blood tubing set
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