ADAPTER AP40AST AFFINITY CP WW
Affinity™ - AP40AST
Device Description
A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.
Environmental Conditions
- Do not store at extremes of temperature and humidity.
- Keep dry
- Avoid storing the adapter in direct sunlight.
- 106.30
- 70.00
- 93.00
- 15.00
- 70.00
- -30.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KFM
Device Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.4360
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00643169272248
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