| Primary Device ID | 00840241600382 |
| NIH Device Record Key | 895b5640-6828-492f-b17c-bf893a639667 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kestra Provided Device Patient Application |
| Version Model Number | 80740-001 |
| Catalog Number | 80740-001 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840241600382 [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 | 2024-09-26 |
| Device Publish Date | 2024-09-18 |
| 00840241600313 - ASSURE Wearable ECG | 2024-09-26 A wearable cardiac episode recorder |
| 00840241600320 - Battery | 2024-09-26 A rechargeable battery that powers the ASSURE Wearable ECG |
| 00840241600337 - System Cable | 2024-09-26 Provides the connection between an ASSURE Garment and a Battery |
| 00840241600344 - ASSURE Assist Service | 2024-09-26 The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occu |
| 00840241600382 - Kestra Provided Device Patient Application | 2024-09-26ASSURE Patient Application for the Kestra Provided Device. |
| 00840241600382 - Kestra Provided Device Patient Application | 2024-09-26 ASSURE Patient Application for the Kestra Provided Device. |
| 00840241600238 - ASSURE WCD System | 2023-07-04 The ASSURE Wearable Cardioverter Defibrillator System |
| 00840241600283 - ASSURE Patient Application | 2023-03-21 ASSURE patient app is a component of CareStation. |
| 00840241600306 - CareStation Server | 2023-03-20 CareStation Server acquires and displays data from the WCD for clinicians to view. |