GUDID 00763000970680

CUSTOM PACK BB10A15R12 SM AV LOOP

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00763000970680
• NIH Device Record Key: 74f40838-c850-4117-a10c-266cbd83eefa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB10A15R12
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000970680 [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: 2024-08-26
• Device Publish Date: 2024-08-17

Devices Manufactured by MEDTRONIC, INC.

• 00763000971083 - NA: 2024-08-27 CUSTOM PACK BB7P41R9 38-38
• 00763000971373 - NA: 2024-08-27 CUSTOM PACK BB11U19R7 ADLT CPB
• 00763000971472 - NA: 2024-08-27 CUSTOM PACK 7N24R12 VAP W38 AVL
• 00763000918934 - TurboHawk™: 2024-08-26 ATHERECTOMY TH-LX-M TURBOHAWK ATK SC UNI
• 00763000918941 - TurboHawk™: 2024-08-26 ATHERECTOMY THS-SS-CL TURBOHAWK BTK HECO
• 00763000918958 - TurboHawk™: 2024-08-26 ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC O
• 00763000970093 - NA: 2024-08-26 CUSTOM PACK BB7P46R9 316-14
• 00763000970680 - NA: 2024-08-26CUSTOM PACK BB10A15R12 SM AV LOOP
• 00763000970680 - NA: 2024-08-26 CUSTOM PACK BB10A15R12 SM AV LOOP