Affinity Fusion™
GUDID 00763000834210
OXYGENATOR BB811 FUSION BALANCE 2L
MEDTRONIC, INC.
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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