Affinity NT™

GUDID 20763000232126

FPA 95217 AFFINITY TRILLIUM GLBL

MEDTRONIC, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20763000232126
• NIH Device Record Key: 25e102c5-1d61-44fd-8b54-28f758f068c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity NT™
• Version Model Number: 95217
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000232122 [Primary]
GS1	20763000232126 [Package]; Contains: 00763000232122; Package: PK [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191029

FDA Product Code

• DTZ: OXYGENATOR, 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: 2020-01-29
• Device Publish Date: 2020-01-21

On-Brand Devices [Affinity NT™]

• 00643169767843: OXYGENATOR CB511 AFFINITY BIOACT 4PK
• 00643169767805: OXYGENATOR CB541 AFFINITY PKGNG ASSY 2PK
• 20763000187846: ICVR 541B BALANCE AFFINITY NT GLBL
• 20763000232126: FPA 95217 AFFINITY TRILLIUM GLBL
• 20763000232089: FPA 95215 AFFINITY TRILLIUM GLBL
• 20763000232140: FPA 95250 AFFINITY TRILLIUM GLBL