| Primary Device ID | 00613994952400 |
| NIH Device Record Key | 1510cd69-ac72-49de-8feb-1360a4b44b82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDTRONIC CARELINK EXPRESS™ |
| Version Model Number | 2020B1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994952400 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| 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 | 2014-10-09 |
| 00613994952431 | MON 2020C1 CARELINK USA EXPRESS MONITOR |
| 00613994952400 | MON 2020B1 CARELINK USA EXPRESS MONITOR |
| 00643169107052 | MON 2020B2 CARELINK USA MR4 MONITOR |
| 00643169312081 | MON 2020C2 CARELINK 60601 3ED USA |
| 00643169192058 | MON 2020B3 CARELINK USA BW 60601 |