Affinity

GUDID 50613994010792

RESERVOIR 61399401079 AFFINITY 8CA VN321

MEDTRONIC, INC.

Cardiotomy reservoir

• Primary Device ID: 50613994010792
• NIH Device Record Key: f0a436e5-7e01-4e14-94a8-cf813cf5d0f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity
• Version Model Number: 61399401079
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 8
• 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	00613994010797 [Unit of Use]
GS1	50613994010792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935717

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: 2016-09-24

Devices Manufactured by MEDTRONIC, INC.

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• 00763000180058 - Sprint Quattro Secure S MRI™ SureScan™: 2024-11-12 LEAD 693565 SPRINT MRI US RCMCRD
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• 00763000180126 - Sprint Quattro Secure S MRI™ SureScan™: 2024-11-12 LEAD 6935M62 MRI US DF4 RCMCRD
• 00763000180133 - Sprint Quattro Secure S™: 2024-11-12 LEAD 6935M49 US DF4 RCMCRD