CBC II

CBC II
NA - 0225426000W

An assembly of manual devices intended to be used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after surgery. It is a closed-circuit system that typically includes a manual aspiration (suction) pump, a collection container, reinfusion bag, safety clamps, non-return valves, blood screening filters, and a transfusion set; a drain(s) and/or trocar(s) may also be included in the system. It may facilitate connection to the wall outlet of a vacuum system for aspiration. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CAC

Device Name: Apparatus, Autotransfusion

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: 868.5830

Third Party Flag: N

Medical Specialty: AN

Device Id: 37613327051279

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327051278

Package Quantity: 6

Package Discontinue Date: 12/31/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: pack

Device Id: 07613327051278

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