GUDID 20199150021714

CUSTOM PACK BB11H35R5 5PK SUPP PCK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150021714
• NIH Device Record Key: ae15ed47-b85d-4b09-b3d4-d5c867eeb40d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB11H35R5
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150021703 [Primary]
GS1	20199150021714 [Package]; Contains: 00199150021703; 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: 2025-06-16
• Device Publish Date: 2025-06-07

Devices Manufactured by MEDTRONIC, INC.

• 20199150021677 - NA: 2025-06-16 CUSTOM PACK BB9H02R8 4PK 1/4A 3/8V
• 00199150021680 - NA: 2025-06-16 CUSTOM PACK BB10T89R3 3/8 ECC
• 00199150021697 - NA: 2025-06-16 CUSTOM PACK BB1B37R38 E WO R
• 20199150021714 - NA: 2025-06-16CUSTOM PACK BB11H35R5 5PK SUPP PCK
• 20199150021714 - NA: 2025-06-16 CUSTOM PACK BB11H35R5 5PK SUPP PCK
• 00199150022519 - NA: 2025-06-16 CUSTOM PACK BB11R06R3 SUPP 1/4 PK
• 00199150022526 - NA: 2025-06-16 CUSTOM PACK BB11N34R9 VVL
• 00199150022533 - NA: 2025-06-16 CUSTOM PACK BB5W59R5 LEVITRON
• 00199150023721 - NA: 2025-06-16 CUSTOM PACK BB9F75R9 E SUPPORT