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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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Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934196

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8212
In Commercial Distribution

  • 04710961934196 ()
  • 14710961934193 ()


  • Suprapubic drainage catheter

Rika Plasma Bottle - 05020583213005

elabeling.terumobct.com
TERUMO BCT, INC.
21300
In Commercial Distribution

  • 35020583213006 ()
  • 05020583213005 ()


  • Apheresis kit

Rika Plasma Separation Set - 05020583212008

elabeling.terumobct.com
TERUMO BCT, INC.
21200
In Commercial Distribution

  • 35020583212009 ()
  • 05020583212008 ()


  • Apheresis kit

Alinity - 00380740138783

Alinity h-series WATER PURIFICATION SYSTEM
Abbott GmbH
09P7101
In Commercial Distribution

  • 00380740138783 ()
09P7101

  • Deionization water purification system

ThermoGard XP Surface Start-Up Kit - 00849111076081

The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.
Zoll Circulation, Inc.
Surface Start-Up Kit
In Commercial Distribution

  • 00849111076081 ()
8700-000936-01

  • External circulating-fluid core temperature regulation system start kit

Thermogard HQ Surface Start-Up Kit - 00849111076074

The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature."
Zoll Circulation, Inc.
Surface Start-Up Kit
In Commercial Distribution

  • 00849111076074 ()
8700-000935-01

  • External circulating-fluid core temperature regulation system start kit

B.BRAUN - 04046964231834

HELP HEPARIN ADSORBER 400 US/CA
B.Braun Avitum AG
7211089
Not in Commercial Distribution

  • 04046964231834 ()
  • 04046964231841 ()
7211089

  • Apheresis kit

H.E.L.P.® - 04046964156731

H.E.L.P. ACETATPUFFER HOT US / CA
B.Braun Avitum AG
4469
Not in Commercial Distribution

  • 04046964156731 ()
  • 04046964156724 ()

  • Volume : 4000.000 ML
  • Acidity (pH) : 4.850 PH
  • Acetic acid 99% : 6.820 GLI
  • Sodium acetate x 3 H2O : 27.220 GLI
4469

  • Apheresis kit

B.BRAUN - 04046964133534

HELP FUTURA SET WITH 4 FILTERS (US)
B.Braun Avitum AG
7211091
Not in Commercial Distribution

  • 04046964133534 ()
  • 04046964251153 ()
7211091

  • Apheresis kit

B.BRAUN - 04046964319860

H.E.L.P. Heparin Sodium Solution 30 mL
B.Braun Avitum AG
7061188
Not in Commercial Distribution

  • 04046964319860 ()
  • 04030539195089 ()

  • Concentration (IU/ml) : 10000.000 IE3
  • Volume : 30.000 ML
7061188

  • Apheresis kit
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