Affinity™ CP

GUDID 20613994647867

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 20613994647867
• NIH Device Record Key: bd462af0-ef13-499d-aa6b-c9549f61efde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity™ CP
• Version Model Number: CBAP40
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994647863 [Primary]
GS1	20613994647867 [Package]; Contains: 00613994647863; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111658

FDA Product Code

• KFM: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-14
• Device Publish Date: 2014-09-23

On-Brand Devices [Affinity™ CP]

• 20613994647867: PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
• 20613994647850: PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
• 20613994647843: PUMP AP40 AFFINITY CP CENTRIFUGAL NC
• 20643169855216: PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
• 20643169855209: PUMP AP40 AFFINITY CP CENTRIFUGAL NC
• 20643169855193: PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
• 00643169272231: ADAPTER AP40AST AFFINITY CP US
• 20763000074412: PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
• 20643169785780: PUMP CBAP40 AFF CP CENTRIF CC US/CAN 4PK
• 20643169433254: PUMP AP40 AFFINITY CP CENTRIFUGAL NC
• 20643169433247: PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
• 20643169433230: PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
• 00763000301323: ADAPTER AP40AST AFFINITY CP WW 31L