GUDID 00199150014347

CUSTOM PACK BB11L88R7 SUPPRT SM

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150014347
• NIH Device Record Key: 3a12eb25-b153-4a50-8dfd-da050674806b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB11L88R7
• 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	00199150014347 [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: 2025-05-09
• Device Publish Date: 2025-05-01

Devices Manufactured by MEDTRONIC, INC.

• 00199150007189 - NA: 2025-05-09 CUSTOM PACK BB10Y89R16 ECC 3/8 A/V
• 00199150014347 - NA: 2025-05-09CUSTOM PACK BB11L88R7 SUPPRT SM
• 00199150014347 - NA: 2025-05-09 CUSTOM PACK BB11L88R7 SUPPRT SM
• 20199150003734 - NA: 2025-05-06 CUSTOM PACK BB10C88R1 5PK PRIME KIT
• 00199150008698 - NA: 2025-05-06 CUSTOM PACK BB11A81R6 RWJ PEDIMAG
• 20199150009200 - NA: 2025-05-06 CUSTOM PACK BB4G73R2 25PK PRT ACCSP
• 00199150009213 - NA: 2025-05-06 CUSTOM PACK BB11L40R5 UCD SM ADLT
• 00199150009251 - NA: 2025-05-06 CUSTOM PACK BB4Z56R7 CSP L SUP
• 00199150009268 - NA: 2025-05-06 CUSTOM PACK BB12P00R3 SUTTER MCS