GUDID 00199150030842

CUSTOM PACK BB8B05R17 HBC

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150030842
• NIH Device Record Key: 1b1a4045-0992-41a5-b2ba-b307d84920ad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB8B05R17
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150030842 [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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by MEDTRONIC, INC.

• 00199150030842 - NA: 2025-07-15CUSTOM PACK BB8B05R17 HBC
• 00199150030842 - NA: 2025-07-15 CUSTOM PACK BB8B05R17 HBC
• 00199150026654 - NA: 2025-07-07 CUSTOM PACK BB11E82R2 CB E SUPP
• 00199150026661 - NA: 2025-07-07 CUSTOM PACK BB7D23R7 RADL
• 00199150026722 - NA: 2025-07-07 CUSTOM PACK BB8T30R14 3/8 COMER
• 00199150026739 - NA: 2025-07-07 CUSTOM PACK BB12B00R3 3/8 SUPPORT
• 20199150026887 - NA: 2025-07-07 CUSTOM PACK BB8M18R1 2PK 1/4 LINES
• 00199150026890 - NA: 2025-07-07 CUSTOM PACK BB6U14R7 TABLE PK
• 00199150026906 - NA: 2025-07-07 CUSTOM PACK BB11S65R3 UAB L U N G T