GUDID 00199150038176

CUSTOM PACK BB11M68R6 PEDI SUPPORT

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150038176
• NIH Device Record Key: b694e975-3a84-4e80-a296-a68945df7351
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB11M68R6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150038176 [Primary]

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: 2025-08-13
• Device Publish Date: 2025-08-05

Devices Manufactured by MEDTRONIC, INC.

• 00199150037995 - NA: 2025-08-15 CUSTOM PACK BB12P51R4 EVL ORS PK
• 00199150038060 - NA: 2025-08-15 CUSTOM PACK BB12P06R CONE EXCHANGE
• 00199150038800 - NA: 2025-08-15 CUSTOM PACK BB12N98R 1/4 KIT
• 00199150038930 - NA: 2025-08-15 CUSTOM PACK BB12B01R2 PEDS CH ADAPT
• 00199150039043 - NA: 2025-08-15 CUSTOM PACK BB8M10R14 E SUPPORT
• 00199150039050 - NA: 2025-08-15 CUSTOM PACK BB6M86R4 INFT V
• 00199150039067 - NA: 2025-08-15 CUSTOM PACK BB11F63R2 PEDI ADAPTATI
• 00199150039210 - NA: 2025-08-15 CUSTOM PACK BB11U75R5 GOLD PACK