- Physicians Office Resource

CAPIOX® SP PUMP
CAPIOX® SP PUMP - CX*SP45

Device Description

A mains electricity (AC-powered), specially constructed, centrifugal pump that is used to maintain blood circulation in heart failure. It is used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function. This dependence will be due to the lack of the heart's ability to function normally. The pump may be used during open heart surgery and postoperatively for a short period to assist the heart in regaining function.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

40.00
1.00

Special Storage Condition, Specify

Keep away from rain.

Special Storage Condition, Specify

Keep away from sunlight.

Special Storage Condition, Specify

This way up.

Special Storage Condition, Specify

Fragile

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: 04987350706119

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

Device Id: 54987350706114

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350706119

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: 10 Piece Case

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