- Physicians Office Resource

CAPIOX®ARTERIAL FILTER - CX*AF02

Device Description

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.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

40.00
1.00

Special Storage Condition, Specify

Fragile. This way up. Keep away from sunlight. Keep away from rain.

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 54987350705636

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350705631

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04987350705631

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

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