OXYGENATOR CBP211 NI CB STERILE NCE
Affinity Pixie™ - CBP211
Device Description
A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.
Environmental Conditions
- 40.00
- N/A
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DTZ
Device Name: Oxygenator, Cardiopulmonary Bypass
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.4350
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 20613994617273
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00613994617279
Package Quantity: 4
Package Discontinue Date: 10/21/2019 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: PK
Device Id: 00613994617279
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A