GUDID 00199150007028

CUSTOM PACK BB4W67R24 ADULT E

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150007028
• NIH Device Record Key: a26c5aaa-d41f-4888-9065-96f8c2050f65
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB4W67R24
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150007028 [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: 2025-04-22
• Device Publish Date: 2025-04-14

Devices Manufactured by MEDTRONIC, INC.

• 00199150006434 - NA: 2025-04-22 CUSTOM PACK BB11P23R4 LARGO DUAL V
• 00199150006465 - NA: 2025-04-22 CUSTOM PACK BB12E01R8 MAINPCK
• 00199150006618 - NA: 2025-04-22 CUSTOM PACK BB6N93R9 OSF ADPTR
• 00199150006861 - NA: 2025-04-22 CUSTOM PACK BB6Y28R11 CMAG L I V
• 00199150006878 - NA: 2025-04-22 CUSTOM PACK BB6Y37R3 CP PRIME
• 20199150006896 - NA: 2025-04-22 CUSTOM PACK BB10Y97R1 5PK MANIFOLD
• 20199150006919 - NA: 2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y
• 00199150006922 - NA: 2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD