- Physicians Office Resource

CAPIOX CARDIOPLEGIA
CAPIOX - ZZ*CP50A

Device Description

A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.

Special Storage Condition, Specify

AVOID DIRECT SUNLIGHT.

Storage Environment Temperature - Degrees Celsius

40.00
1.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DTR

Device Name: Heat-Exchanger, 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: 870.4240

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 54987350743256

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350743251

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 04987350743251

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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