RESERVOIR 61399401043 1EA BLADDER R14

RESERVOIR 61399401043 1EA BLADDER R14
NA - 61399401043

A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DTN

Device Name: Reservoir, Blood, 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: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.4400

Third Party Flag: Y

Medical Specialty: CV

Device Id: 30613994010439

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: 50613994010433

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30613994010439

Package Quantity: 5

Package Discontinue Date: 7/23/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: PK

Device Id: 70613994010437

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 50613994010433

Package Quantity: 4

Package Discontinue Date: 7/23/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CT