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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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DiaSpect Control HBT4 - 04048534002004

For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
EKF-diagnostic GmbH
7049-6214
In Commercial Distribution

  • 04048534002004 ()
900-504

  • Total haemoglobin (totHb) IVD, control

DiaSpect Tm - 04048534001946

For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-0013-0264
In Commercial Distribution

  • 04048534001946 ()
900-001

  • Haemoglobin analyser IVD, point-of-care

DiaSpect Control Pack HBT4 - 04048534001588

For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
DiaSpect Medical GmbH
90B.0014
In Commercial Distribution

  • 04048534001588 ()


  • Total haemoglobin (totHb) IVD, control

DiaSpect Control Pack HBT3 - 04048534001571

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

DiaSpect Control Pack HBT2 - 04048534001564

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

DiaSpect Control Pack HBT1 - 04048534001557

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

DiaSpect Hemoglobin Cuvettes - 04048534001540

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

Compumedics Okti - 09342451002228

Okti 128 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 128
In Commercial Distribution

  • 09342451002228 ()
8029-0004-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder

Compumedics Okti - 09342451002211

Okti 64 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 64
In Commercial Distribution

  • 09342451002211 ()
8029-0003-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder

Compumedics Okti - 09342451002204

Okti 32 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 32
In Commercial Distribution

  • 09342451002204 ()
8029-0002-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
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