TRILLIUM™ AFFINITY®NT

GUDID 20721902648759

RESERVOIR 95249 AFFINITY 4CA CVR-T 540T

MEDTRONIC, INC.

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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• 00763000579388 - N/A: 2025-02-18 TELEMETRY MODULE TM90Q0 ISTIM X US
• 00763000879297 - NA: 2025-02-18 TELEMETRY TM90Q0 ISTIM X US EMAN
• 00763000988777 - NA: 2025-02-17 CUSTOM PACK BB6Z71R15 VA
• 20763000998145 - NA: 2025-02-17 CUSTOM PACK SSBB12N37R 10PK LOWER LMB
• 00763000998424 - NA: 2025-02-17 CUSTOM PACK BB10Z65R1 V A D
• 00763000517830 - Hancock™: 2025-02-14 CONDUIT HC15022 HK1 MO 26L
• 00763000995775 - NA: 2025-02-14 CUSTOM PACK BB11W65R2 SPECTRUM CPB