GUDID 20673978538383

CELL 1473R1 TMC25 W/6 IN EXTENSION

MEDTRONIC, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20673978538383
• NIH Device Record Key: fd7206ba-86d5-4d62-a936-932f82a569c3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1473R1
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978538389 [Unit of Use]
GS1	20673978538383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800178

FDA Product Code

• DRY: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2018-12-22

Devices Manufactured by MEDTRONIC, INC.

• 20763000651736 - Aortic Punch: 2025-03-31 Aortic Punch APU425 - 2.5mm punch size
• 20763000651743 - Aortic Punch: 2025-03-31 Aortic Punch APU430 - 3.0mm punch size
• 20763000651750 - Aortic Punch: 2025-03-31 Aortic Punch APU435 - 3.5mm punch size
• 20763000651767 - Aortic Punch: 2025-03-31 Aortic Punch APU440 - 4.0mm punch size
• 20763000651774 - Aortic Punch: 2025-03-31 Aortic Punch APU444 - 4.4mm punch size
• 20763000651781 - Aortic Punch: 2025-03-31 Aortic Punch APU448 - 4.8mm punch size
• 20763000651798 - Aortic Punch: 2025-03-31 Aortic Punch APU450 - 5.0mm punch size
• 20763000651804 - Aortic Punch: 2025-03-31 Aortic Punch APU452 - 5.2mm punch size