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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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No Description
Roche Molecular Systems, Inc.
07886985001
In Commercial Distribution

  • 07613336119570 ()
07886985001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07886977001
Not in Commercial Distribution

  • 07613336119563 ()
07886977001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07341920190
Not in Commercial Distribution

  • 07613336100097 ()
07341920190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCR-ADAA00000
In Commercial Distribution

  • B769ICRADAA00000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Guardian Warmer w/ Control Box Hangers, Evaluation
Medela LLC
NGW2000M
In Commercial Distribution

  • 10020451101696 ()
  • 00020451101699 ()


  • Conduction blood/fluid warmer
Guardian Warmer, Evaluation
Medela LLC
NGW1000M
Not in Commercial Distribution

  • 10020451101689 ()
  • 00020451101682 ()


  • Conduction blood/fluid warmer
CPAP Tubing, 18 inch, single-pack
EXCELERON MEDICAL, INC.
CTUB-018-1
In Commercial Distribution

  • 10819989011184 ()
  • 00819989011187 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 4 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-040-1
In Commercial Distribution

  • 00819989011163 ()
  • 10819989011160 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 2 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-020-1
In Commercial Distribution

  • 00819989011149 ()
  • 10819989011146 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 6 ft (Spirit Labeled), single-pack
EXCELERON MEDICAL, INC.
CPAP-TUBE-6FT-SPL-1
In Commercial Distribution

  • 00819989011125 ()
  • 10819989011122 ()


  • Ventilator breathing circuit, single-use
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