| Primary Device ID | 00199150042043 |
| NIH Device Record Key | 645f144e-47fe-45e8-b58e-7e4764221a4f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BB9E98R16 |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00199150042043 [Primary] |
| DWF | Catheter, cannula and tubing, vascular, 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 | 2025-08-29 |
| Device Publish Date | 2025-08-21 |
| 00199150042005 - NA | 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8 |
| 00199150042012 - NA | 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM |
| 00199150042029 - NA | 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4 |
| 00199150042043 - NA | 2025-08-29CUSTOM PACK BB9E98R16 EVL WCH PED |
| 00199150042043 - NA | 2025-08-29 CUSTOM PACK BB9E98R16 EVL WCH PED |
| 00199150042067 - NA | 2025-08-29 CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4 |
| 00199150042739 - NA | 2025-08-29 CUSTOM PACK BB7V67R13 HLO PRESBY |
| 00199150042746 - NA | 2025-08-29 CUSTOM PACK BB0C00R32 EVL 3/8SUPPT |
| 00763000658960 - Profile 3D™ | 2025-08-29 HANDLE 7686L ANNULOPLASTY2 MDR |