Affinity™ CP

GUDID 20763000074412

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 20763000074412
• NIH Device Record Key: f2d5147b-50b9-4813-aefd-95d84f92d1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity™ CP
• Version Model Number: CBAP40
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 4
• 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
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000074418 [Unit of Use]
GS1	20763000074412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132712

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-04
• Device Publish Date: 2019-02-01

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