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 Class Implantable

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Reusable Thermometer Probe/20K/Adult/Skin/LP2单公/1.6M/郑州迪生
Unimed Medical Supplies, Inc.
TDS-16AS
In Commercial Distribution

  • 06945664856577 ()


  • General-purpose patient temperature probe, reusable
CARTRIDGE, CG4+
ABBOTT POINT OF CARE INC.
03P85-50
Not in Commercial Distribution

  • 10054749002266 ()
  • 00054749002269 ()
03P85-50

  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Lactate electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
CG4+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P85-25
In Commercial Distribution

  • 10054749000132 ()
  • 00054749000135 ()
03P85-25

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Lactate electrode IVD
Lactate_3 (LAC_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537218
In Commercial Distribution

  • 00630414305066 ()
  • 00630414610979 ()
11537218

  • Lactate IVD, kit, spectrophotometry
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11532568
Not in Commercial Distribution

  • 00630414287270 ()
11532568

  • Lactate IVD, kit, spectrophotometry
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc.
10492730
In Commercial Distribution

  • 00630414589169 ()
10492730

  • Blood gas/haemoximetry analyser IVD, point-of-care
No Description
APEX BIOTECHNOLOGY CORP.
The EDGE control solution
In Commercial Distribution

  • 04713648766554 ()


  • Lactate IVD, control
25s
APEX BIOTECHNOLOGY CORP.
The EDGE test strip
In Commercial Distribution

  • 04713648766547 ()


  • Lactate monitoring system IVD, home-use
KIT
APEX BIOTECHNOLOGY CORP.
The EDGE meter
In Commercial Distribution

  • 04713648766530 ()


  • Lactate monitoring system IVD, home-use
No Description
RANDOX LABORATORIES LIMITED
LC3980
In Commercial Distribution

  • 05055273204094 ()


  • Lactate IVD, kit, spectrophotometry
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