GUDID 20673978538420

CELL 1475R1 TMC50 W/6 INCH EXTENSION

MEDTRONIC, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20673978538420
• NIH Device Record Key: c7a9208a-266e-488e-a0f2-ec092220b3b6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1475R1
• 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: 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	00673978538426 [Primary]
GS1	20673978538420 [Package]; Contains: 00673978538426; Package: PK [12 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-09-04

Devices Manufactured by MEDTRONIC, INC.

• 00763000661588 - Profile 3D™: 2025-09-16 RING 680R24 PROFILE 3D MEXICO MDR
• 00763000661595 - Profile 3D™: 2025-09-16 RING 680R26 PROFILE 3D MEXICO MDR
• 00763000661601 - Profile 3D™: 2025-09-16 RING 680R28 PROFILE 3D MEXICO MDR
• 00763000661618 - Profile 3D™: 2025-09-16 RING 680R30 PROFILE 3D MEXICO MDR
• 00763000661625 - Profile 3D™: 2025-09-16 RING 680R32 PROFILE 3D MEXICO MDR
• 00763000661632 - Profile 3D™: 2025-09-16 RING 680R34 PROFILE 3D MEXICO MDR
• 00763000661649 - Profile 3D™: 2025-09-16 RING 680R36 PROFILE 3D MEXICO MDR
• 00763000661656 - Profile 3D™: 2025-09-16 RING 680R38 PROFILE 3D MEXICO MDR