GUDID 00763000024338

CUSTOM PACK BB9P41R5 SIERRA FU

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00763000024338
• NIH Device Record Key: ec325a28-8cc9-46e4-b70a-a368f8993e5e
• Commercial Distribution Discontinuation: 2018-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: BB9P41R5
• 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
• 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 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000024338 [Primary]

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: 4
• Public Version Date: 2018-12-11
• Device Publish Date: 2017-08-13

Devices Manufactured by MEDTRONIC, INC.

• 20763000990286 - NA: 2026-03-24 CUSTOM PACK BB12M54R1 10PK 1/4 LINE
• 20763000284897 - OctoBase™: 2026-03-23 INSERTS 28707 RETRACTOR DPSH 10PK 31L
• 00199150071623 - NA: 2026-03-16 CUSTOM PACK BB11X36R2 EVL SUPPORT
• 20199150071917 - NA: 2026-03-16 CUSTOM PACK BB8S03R4 10PK EVL ACCESS
• 00199150071920 - NA: 2026-03-16 CUSTOM PACK BB9G55R9 HLO TVA FU
• 00199150071937 - NA: 2026-03-16 CUSTOM PACK BB10P43R7 TRIDENT A
• 00199150071944 - NA: 2026-03-16 CUSTOM PACK BB12R46R1 EVL TABLE
• 20199150072020 - NA: 2026-03-16 CUSTOM PACK BB12T66R 10PK AVL HALI