GUDID 20763000352879

CUSTOM PACK 11E60R 5PK OXY LINE

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 20763000352879
• NIH Device Record Key: 181e4c0b-b23d-41d1-818b-bc52e38577f1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 11E60R
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000352868 [Primary]
GS1	20763000352879 [Package]; Contains: 00763000352868; Package: PK [5 Units]; In Commercial Distribution

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: 2020-02-10
• Device Publish Date: 2020-02-01

Devices Manufactured by MEDTRONIC, INC.

• 00763000613617 - Mosaic™7308C: 2025-03-11 SIZERS 7308C MOSAIC CINCH AORTIC MDR
• 00763000613624 - Mosaic Ultra™7308U: 2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR
• 00763000613631 - Mosaic™7310: 2025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR
• 00763000613648 - NA: 2025-03-11 HANDLE 7639 VALVE MDR
• 00763000613655 - NA: 2025-03-11 HANDLE 7639XL VALVE XL MDR
• 00763000613662 - NA: 2025-03-11 ACCESSORY 7642 LOCK NUT MDR
• 00763000614034 - Hancock™ II 7505: 2025-03-11 OBTURATOR 7505SET HK II AORTIC MDR
• 00763000614041 - Hancock™ II 7510: 2025-03-11 OBTURATOR 7510SET HK II MITRAL MDR