BIO-PUMP+®

GUDID 20613994406945

PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK

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: 20613994406945
• NIH Device Record Key: 50e4a4de-88a5-4aad-8e4a-7d0dbada3c67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-PUMP+®
• Version Model Number: 95201
• 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: true
• 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 -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994406941 [Primary]
GS1	20613994406945 [Package]; Contains: 00613994406941; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973011

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [BIO-PUMP+®]

• 00613994529213: PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
• 00613994413024: PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
• 20613994406945: PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK
• 00721902817403: PUMP CBBPX-80 BIOPUMP 1EA CBBPX80 AD ST