| Primary Device ID | 20613994885894 |
| NIH Device Record Key | d81f5e6b-75eb-4721-86aa-d68160dd95ea |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 004502 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 100 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994885890 [Unit of Use] |
| GS1 | 20613994885894 [Primary] |
| DQX | WIRE, GUIDE, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-11 |
| 00199150037995 - NA | 2025-08-15 CUSTOM PACK BB12P51R4 EVL ORS PK |
| 00199150038060 - NA | 2025-08-15 CUSTOM PACK BB12P06R CONE EXCHANGE |
| 00199150038800 - NA | 2025-08-15 CUSTOM PACK BB12N98R 1/4 KIT |
| 00199150038930 - NA | 2025-08-15 CUSTOM PACK BB12B01R2 PEDS CH ADAPT |
| 00199150039043 - NA | 2025-08-15 CUSTOM PACK BB8M10R14 E SUPPORT |
| 00199150039050 - NA | 2025-08-15 CUSTOM PACK BB6M86R4 INFT V |
| 00199150039067 - NA | 2025-08-15 CUSTOM PACK BB11F63R2 PEDI ADAPTATI |
| 00199150039210 - NA | 2025-08-15 CUSTOM PACK BB11U75R5 GOLD PACK |