| Primary Device ID | 00840241600252 |
| NIH Device Record Key | a10b927d-dade-4826-bcfa-47f40b187af6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASSURE Patient Application |
| Version Model Number | 80429-003 |
| Catalog Number | 80429-003 |
| Company DUNS | 060944361 |
| Company Name | Kestra Medical Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx | |
| Phone | 1.833.692.7787 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840241600214 [Previous] |
| GS1 | 00840241600252 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-04 |
| Device Publish Date | 2022-06-24 |
| 00840241600214 | ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStat |
| 00840241600252 | ASSURE patient app is a component of CareStation. |
| 00840241600283 | ASSURE patient app is a component of CareStation. |