BIO-PUMP+®

GUDID 20613994406945

PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK

MEDTRONIC, INC.

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