Affinity®

GUDID 20613994309338

FILTER S4014 AFFINITYPEDIATRIC ART ST

MEDTRONIC, INC.

Cardiopulmonary bypass system filter, arterial blood line

• Primary Device ID: 20613994309338
• NIH Device Record Key: 7d3bb4c9-88a5-4432-a606-6c51d49aa833
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity®
• Version Model Number: S4014
• 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

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	00613994309334 [Primary]
GS1	20613994309338 [Package]; Contains: 00613994309334; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071253

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-17

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