GUDID 00199150042067

CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150042067
• NIH Device Record Key: 745c3e83-e92a-4237-a17f-7a72f8c0bf49
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB7E31R31
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150042067 [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: 2025-08-29
• Device Publish Date: 2025-08-21

Devices Manufactured by MEDTRONIC, INC.

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• 00199150042029 - NA: 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4
• 00199150042043 - NA: 2025-08-29 CUSTOM PACK BB9E98R16 EVL WCH PED
• 00199150042067 - NA: 2025-08-29CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4
• 00199150042067 - NA: 2025-08-29 CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4
• 00199150042739 - NA: 2025-08-29 CUSTOM PACK BB7V67R13 HLO PRESBY
• 00199150042746 - NA: 2025-08-29 CUSTOM PACK BB0C00R32 EVL 3/8SUPPT
• 00763000658960 - Profile 3D™: 2025-08-29 HANDLE 7686L ANNULOPLASTY2 MDR