- Physicians Office Resource

Bilateral Evacuator Tube Set
NA - 0215089000

Device Description

An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GCY

Device Name: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: SU

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: 878.4680

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 34546540865053

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04546540865052

Package Quantity: 10

Package Discontinue Date: 3/31/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: pack

Device Id: 04546540865052

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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