TRILLIUM® Affinity®

GUDID 20721902363591

FILTER 351T TRILL AFFINITY

MEDTRONIC, INC.

Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line

• Primary Device ID: 20721902363591
• NIH Device Record Key: 1654e7ab-b6fa-4019-ab43-c44747a6f039
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TRILLIUM® Affinity®
• Version Model Number: 351T
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Pore Size: 38 Micrometer
• Pore Size: 38 Micrometer

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	00721902363597 [Primary]
GS1	20721902363591 [Package]; Contains: 00721902363597; Package: PK [6 Units]; Discontinued: 2018-10-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013084

FDA Product Code

• DTM: Filter, blood, cardiopulmonary bypass, arterial line

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: 2018-12-19
• Device Publish Date: 2015-08-17

On-Brand Devices [TRILLIUM® Affinity®]

• 20721902363591: FILTER 351T TRILL AFFINITY
• 20885074252227: FILTER 353T AFFINITY 20M TRILLIUM 6PK