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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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therMaxTherMax Blood Warmer - 00085412639505

The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids.
BAXTER HEALTHCARE CORPORATION
955630
In Commercial Distribution

  • 00085412639505 ()
955630

  • Conduction blood/fluid warmer

BF - 00026072025024

VENT CIRCUIT TUBING HAN-
Allied Medical, LLC
64600
In Commercial Distribution

  • 00026072025024 ()


  • Ventilator breathing circuit, single-use

Enteral Feeding - 00020451101699

Guardian Warmer w/ Control Box Hangers, Evaluation
Medela LLC
NGW2000M
In Commercial Distribution

  • 10020451101696 ()
  • 00020451101699 ()


  • Conduction blood/fluid warmer

Enteral Feeding - 00020451101682

Guardian Warmer, Evaluation
Medela LLC
NGW1000M
Not in Commercial Distribution

  • 10020451101689 ()
  • 00020451101682 ()


  • Conduction blood/fluid warmer

BF - 00026072023655

UNIV/APS'AP4 PART A CIR-
Allied Medical, LLC
81351
In Commercial Distribution

  • 40026072023653 ()
  • 00026072023655 ()


  • Ventilator breathing circuit, single-use

CPAP Tubing - 00819989011187

CPAP Tubing, 18 inch, single-pack
EXCELERON MEDICAL, INC.
CTUB-018-1
In Commercial Distribution

  • 10819989011184 ()
  • 00819989011187 ()


  • Ventilator breathing circuit, single-use

CPAP Tubing - 00819989011163

CPAP Tubing, 4 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-040-1
In Commercial Distribution

  • 00819989011163 ()
  • 10819989011160 ()


  • Ventilator breathing circuit, single-use

CPAP Tubing - 00819989011149

CPAP Tubing, 2 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-020-1
In Commercial Distribution

  • 00819989011149 ()
  • 10819989011146 ()


  • Ventilator breathing circuit, single-use

CPAP Tubing - 00819989011125

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

CPAP Tubing - 00819989011101

CPAP Tubing, 10 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-100-1
In Commercial Distribution

  • 00819989011101 ()
  • 10819989011108 ()


  • Ventilator breathing circuit, single-use
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