| Primary Device ID | 00643169838512 |
| NIH Device Record Key | a946494a-4496-46fd-8811-d4117b07d84a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 450001-015 |
| Company DUNS | 061079989 |
| Company Name | Medtronic Care Management Services, LLC |
| 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169838512 [Primary] |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-09-08 |
| 00643169838482 - NA | 2019-07-22 BP CUFF REGULAR SMALL BP-D01 |
| 00643169838499 - NA | 2019-07-22 BP CUFF REGULAR MEDIUM BP-D02 |
| 00643169838505 - NA | 2019-07-22 BP CUFF REGULAR LARGE BP-D03 |
| 00643169838512 - NA | 2019-07-22BP CUFF CONTOUR MEDIUM BP-D02 |
| 00643169838512 - NA | 2019-07-22 BP CUFF CONTOUR MEDIUM BP-D02 |
| 00643169838529 - NA | 2019-07-22 BP CUFF CONTOUR LARGE BP-D03 |
| 00763000286972 - Commander Flex™ | 2019-07-16 HUB CD320 CMDR FLEX - GA |
| 00763000286989 - Commander Flex™ | 2019-07-16 HUB CD320 CMDR FLEX - CA |
| 00763000286996 - Commander Flex™ | 2019-07-16 HUB CD320 CMDR FLEX - CV |