GUDID 20199150000344

CUSTOM PACK BB8S27R1 5PK Y LINE CB

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150000344
• NIH Device Record Key: 7248e44e-89b7-43f4-9fe4-26df6c27de06
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB8S27R1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150000333 [Primary]
GS1	20199150000344 [Package]; Contains: 00199150000333; 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: 2025-03-14
• Device Publish Date: 2025-03-06

Devices Manufactured by MEDTRONIC, INC.

• 00199150000296 - NA: 2025-03-14 CUSTOM PACK BB10R33R2 WHLG SUPT
• 00199150000302 - NA: 2025-03-14 CUSTOM PACK BB12D68R1 1/4 DAV PK
• 20199150000320 - NA: 2025-03-14 CUSTOM PACK BB10V15R5 5PK SUPP
• 20199150000344 - NA: 2025-03-14CUSTOM PACK BB8S27R1 5PK Y LINE CB
• 20199150000344 - NA: 2025-03-14 CUSTOM PACK BB8S27R1 5PK Y LINE CB
• 20199150000368 - NA: 2025-03-14 CUSTOM PACK BB11P52R1 5PK Y LINE CB
• 00199150000616 - NA: 2025-03-14 CUSTOM PACK BB11N74R15 CCS-ST MARKS
• 00199150000623 - NA: 2025-03-14 CUSTOM PACK BB7E57R18 PUMP
• 00199150000630 - NA: 2025-03-14 CUSTOM PACK BB11B96R4 HEART PACK