Affinity Fusion™
GUDID 20643169178025
RECIR LINE RCL841 FOR FUSION OXY/CVR
MEDTRONIC, INC.
Cardiopulmonary bypass system tubing set| Primary Device ID | 20643169178025 |
| NIH Device Record Key | 6944190e-d053-497c-8a78-df2e15c3c65f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affinity Fusion™ |
| Version Model Number | RCL841 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 12 |
| 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
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169178021 [Unit of Use] |
| GS1 | 20643169178025 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122913
FDA Product Code
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, 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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-17 |
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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