Primary Device ID | 00763000225476 |
NIH Device Record Key | 91457417-3efb-49b9-ac79-20d9a28d41c2 |
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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000225476 [Primary] |
DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-29 |
Device Publish Date | 2020-01-21 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AFFINITY FUSION 85173318 4332295 Live/Registered |
Medtronic, Inc. 2010-11-10 |