Affinity Fusion™
GUDID 00763000834210
OXYGENATOR BB811 FUSION BALANCE 2L
MEDTRONIC, INC.
Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator| Primary Device ID | 00763000834210 |
| NIH Device Record Key | 5c67dabf-9e0f-4198-b52f-1da333e68488 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affinity Fusion™ |
| Version Model Number | BB811 |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000834210 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230640
FDA Product Code
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-14 |
| Device Publish Date | 2023-08-04 |
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 |
Trademark Results [Affinity Fusion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFINITY FUSION 85173318 4332295 Live/Registered |
Medtronic, Inc. 2010-11-10 |
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