Affinity Fusion®

GUDID 00643169178144

OXY/CVR COMBO BB841 FUSION W/BALANCE

MEDTRONIC, INC.

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 00643169178144
• NIH Device Record Key: 91199ed2-8153-4d96-8f91-fc40995508b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity Fusion®
• Version Model Number: BB841
• 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: 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 Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169178144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122914

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: 2016-05-02

On-Brand Devices [Affinity Fusion®]

• 00643169354876: OXY/CVR COMBO CB841 FUSION W/CARMEDA
• 00643169354869: OXY/CVR COMBO BB841 FUSION W/BALANCE
• 00643169178168: OXYGENATOR BB811 FUSION W/BALANCE
• 00643169178144: OXY/CVR COMBO BB841 FUSION W/BALANCE
• 00643169178090: OXYGENATOR CB811 FUSION W/CARMEDA