TRILLIUM™ AFFINITY®NT

GUDID 20721902648759

RESERVOIR 95249 AFFINITY 4CA CVR-T 540T

MEDTRONIC, INC.

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 20721902648759
• NIH Device Record Key: 95273909-c795-41e7-872b-326dd80ac9d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRILLIUM™ AFFINITY®NT
• Version Model Number: 95249
• 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

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	00721902648755 [Primary]
GS1	20721902648759 [Package]; Contains: 00721902648755; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021287

FDA Product Code

• DTN: RESERVOIR, BLOOD, 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: 2016-06-24

Devices Manufactured by MEDTRONIC, INC.

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• 00763000897680 - Launcher™: 2024-05-15 CATHETER LA6AL40A LA 6F 110CM AL40
• 00763000897697 - Launcher™: 2024-05-15 CATHETER LA6HSIA LA 6F 110CM HSI
• 00763000897703 - Launcher™: 2024-05-15 CATHETER LA6HSIIA LA 6F 110CM HSII
• 00763000897710 - Launcher™: 2024-05-15 CATHETER LA6JCL40A LA 6F 110CM JCL40