FILTER 351T TRILL AFFINITY

FILTER 351T TRILL AFFINITY
TRILLIUM® Affinity® - 351T

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.

• Pore Size: 38.0 Micrometer

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DTM

Device Name: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

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: 870.4260

Third Party Flag: N

Medical Specialty: CV

Device Id: 20721902363591

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00721902363597

Package Quantity: 6

Package Discontinue Date: 10/5/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: PK

Device Id: 00721902363597

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