GUDID 20763000990286

CUSTOM PACK BB12M54R1 10PK 1/4 LINE

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20763000990286
• NIH Device Record Key: f900fe06-f420-484e-87ea-2a4fbcb84593
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12M54R1
• 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 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	00763000990275 [Primary]
GS1	20763000990286 [Package]; Contains: 00763000990275; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171979

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

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: 2026-03-24
• Device Publish Date: 2026-03-16

Devices Manufactured by MEDTRONIC, INC.

• 20763000990286 - NA: 2026-03-24CUSTOM PACK BB12M54R1 10PK 1/4 LINE
• 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