HANDCRANK 95183
NA - 95183-003
Device Description
A centrifugal pump that is manually hand cranked (rotated) by the perfusionist or operator present in order to substitute for the electrically-operated pump during a power outage. It is a specially constructed pump 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.
Environmental Conditions
- Keep Dry
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DWA
Device Name: Control, Pump Speed, Cardiopulmonary Bypass
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: 870.4380
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00673978166858
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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