Affinity NT™
GUDID 20763000232140
FPA 95250 AFFINITY TRILLIUM GLBL
MEDTRONIC, INC.
Extracorporeal membrane oxygenator| Primary Device ID | 20763000232140 |
| NIH Device Record Key | 8974c2a5-8849-406c-9183-879703650531 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affinity NT™ |
| Version Model Number | 95250 |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000232146 [Primary] |
| GS1 | 20763000232140 [Package] Contains: 00763000232146 Package: PK [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191029
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 | 2020-03-09 |
| Device Publish Date | 2020-03-01 |
On-Brand Devices [Affinity NT™]
| 00643169767843 | OXYGENATOR CB511 AFFINITY BIOACT 4PK |
| 00643169767805 | OXYGENATOR CB541 AFFINITY PKGNG ASSY 2PK |
| 20763000187846 | ICVR 541B BALANCE AFFINITY NT GLBL |
| 20763000232126 | FPA 95217 AFFINITY TRILLIUM GLBL |
| 20763000232089 | FPA 95215 AFFINITY TRILLIUM GLBL |
| 20763000232140 | FPA 95250 AFFINITY TRILLIUM GLBL |
Trademark Results [Affinity NT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFINITY NT 75552115 2635702 Live/Registered |
MEDTRONIC, INC. 1998-09-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.