Affinity Fusion™

GUDID 00643169785731

OXYGENATOR CB811 FUSION CORTIVA US

MEDTRONIC, INC.

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 00643169785731
• NIH Device Record Key: 49c6c980-e6a4-4400-9e56-59585d9d61ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity Fusion™
• Version Model Number: CB811
• 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 -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169785731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142784

FDA Product Code

• DTZ: OXYGENATOR, 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: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-01-16

On-Brand Devices [Affinity Fusion™]

• 00643169785762: OXY/CVR COMBO CB841 FUSION CORTIVA US
• 00643169785731: OXYGENATOR CB811 FUSION CORTIVA US
• 20643169178025: RECIR LINE RCL841 FOR FUSION OXY/CVR
• 00763000225476: FPA FUSION OXY CB811 CORTIVA 2L
• 00763000225469: FPA FUSION CB841 CORTIVA US 2L
• 00763000834234: OXY/CVR COMBO BB841 FUSION BALANCE 2L
• 00763000834210: OXYGENATOR BB811 FUSION BALANCE 2L