- Physicians Office Resource

Sarns™ Centrifugal Pump without X-Coating™ - CV-164275

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

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: 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 Identifiers

Device Id: 50699753450337

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00699753450332

Package Quantity: 8

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00699753450332

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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