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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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FLASH Ostial System - M917OCB5019BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 17mm
Verge Medical, Inc.
OCB5019BA
In Commercial Distribution

  • M917OCB5019BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 5.0mm
OCB5019BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB5014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 12mm
Verge Medical, Inc.
OCB5014BA
In Commercial Distribution

  • M917OCB5014BA0 ()

  • Distal Balloon Diameter: 5.0mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB5014BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB4514BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm
Verge Medical, Inc.
OCB4514BA
In Commercial Distribution

  • M917OCB4514BA0 ()

  • Distal Balloon Diameter: 4.5mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB4514BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB4014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm
Verge Medical, Inc.
OCB4014BA
In Commercial Distribution

  • M917OCB4014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 4.0mm
OCB4014BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

Voca - 00781096541676

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Smoke Red
In Commercial Distribution

  • 00781096541676 ()
VCKONGSBSROOSND

  • Spectacle frame

CardioQuip Thermoelectric Cooling (TEC) Lid Module - 00860000846134

The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the CardioQuip Modular Cooler-Heater (MCH) to provide cooling to slow the melting of ice in the tank. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-11TEC
In Commercial Distribution

  • 00860000846134 ()


  • Cardiopulmonary bypass system heating/cooling unit

CardioQuip Refrigeration Module - 00860000846127

The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-10RMS
In Commercial Distribution

  • 00860000846127 ()


  • Cardiopulmonary bypass system heating/cooling unit

CardioQuip Modular Cooler-Heater (MCH) - 00860000846110

The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(m)
In Commercial Distribution

  • 00860000846110 ()


  • Cardiopulmonary bypass system heating/cooling unit

CardioQuip Modular Cooler-Heater (MCH) - 00860000846103

The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(i)
In Commercial Distribution

  • 00860000846103 ()


  • Cardiopulmonary bypass system heating/cooling unit

Quantum - 05060434422491

Hose Kit - 9.5mm Bore 4.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000047-00
In Commercial Distribution

  • 05060434422491 ()
52-000047-00

  • Cardiopulmonary bypass system heating/cooling unit
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