GUDID 20199150071665

CUSTOM PACK BB12S13R1 5PK AVL 3/8

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150071665
• NIH Device Record Key: 2851910e-fb9f-4de6-a867-733c47e7279b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12S13R1
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150071654 [Primary]
GS1	20199150071665 [Package]; Contains: 00199150071654; Package: PK [5 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: 2026-03-10
• Device Publish Date: 2026-03-02

Devices Manufactured by MEDTRONIC, INC.

• 00199150033478 - NA: 2026-03-10 RECHARGE SYSTEM RS7230 US INCEPTIV
• 20199150071313 - NA: 2026-03-10 CUSTOM PACK BB12Q91R 5PK ACC 1/4 INC
• 20199150071337 - NA: 2026-03-10 CUSTOM PACK BB12T57R 5PK ACC BARNES DPC
• 20199150071641 - NA: 2026-03-10 CUSTOM PACK BB12T16R1 2PK AVL ENDEAVOR
• 20199150071665 - NA: 2026-03-10CUSTOM PACK BB12S13R1 5PK AVL 3/8
• 20199150071665 - NA: 2026-03-10 CUSTOM PACK BB12S13R1 5PK AVL 3/8
• 00199150071678 - NA: 2026-03-10 CUSTOM PACK BB5G80R37 E. 1/4 PK
• 20199150071832 - NA: 2026-03-10 CUSTOM PACK BB12T25R 5PK ACC COATED COM
• 00199150071845 - NA: 2026-03-10 CUSTOM PACK BB12B01R5 EVL PEDS C