GUDID 20643169708109

CUSTOM PACK BB9C97R1 10PK LI PERFU

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 20643169708109
• NIH Device Record Key: 4da57e47-025a-4316-a7f5-e14a4a7f8c9f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB9C97R1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169708099 [Primary]
GS1	20643169708109 [Package]; Contains: 00643169708099; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800178

FDA Product Code

• DWE: TUBING, PUMP, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-09

Devices Manufactured by MEDTRONIC, INC.

• 00199150018116 - NA: 2025-05-16 CUSTOM PACK BB7C11R6 3/83/8AVL
• 00199150018123 - NA: 2025-05-16 CUSTOM PACK BB2W85R21 MEMBRANE
• 00199150018741 - NA: 2025-05-16 CUSTOM PACK BB7J97R21 1/4 PED CIRC
• 00199150018758 - NA: 2025-05-16 CUSTOM PACK BB12M28R4 QHLM-FROSTY
• 00199150018765 - NA: 2025-05-16 CUSTOM PACK BB6R82R10 L SUPPORT
• 00199150018772 - NA: 2025-05-16 CUSTOM PACK BB7V90R12 CP PRME
• 00199150018789 - NA: 2025-05-16 CUSTOM PACK BB7C09R8 38X1/2AVL
• 00199150018796 - NA: 2025-05-16 CUSTOM PACK BB10L58R2 SUPPORT LG