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Sign in to claim this brandKestra Medical Technologies, Inc.
US
Last updated September 17, 2026
About
Kestra Medical Technologies is a wearable medical device company providing diagnostic and therapeutic technologies. Learn about the ASSURE Wearable Cardioverter Defibrillator (WCD) for cardiac patients.
From the manufacturer's own website. Source
Information
- Country
- US
- Address
- 3933 Lake Washington Blvd, NE, Kirkland, WA, 98033
- Website
- kestramedical.com
- facebook.com/KestraMedical
- —
- Phone
- +18336927787 (from company website)
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3015185344
- DUNS Number
- —
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ASSURE, Monitor | 80008-003 | FDA UDI | Class III | Active |
| Kestra Provided Device Patient Application | 80740-005 | FDA UDI | Class I | Active |
| ASSURE, Tablet | 80041-001 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style A, Size 4 | 80015-004 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style B, Size 7 | 80016-007 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style A, Size 1 | 80015-001 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style A, Size 5 | 80015-005 | FDA UDI | Class III | Active |
| ASSURE Assist Service | 80739-001 | FDA UDI | Class I | Active |
| CareStation Server | 80605-004 | FDA UDI | Class I | Active |
| CareStation Server | 80605-003 | FDA UDI | Class I | Unknown |
| ASSURE, Garment, Style A, Size 3 | 80015-003 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style B, Size 2 | 80016-002 | FDA UDI | Class III | Active |
| ASSURE, Tablet | 80041-002 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style A, Size 6 | 80015-006 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style A, Size 2 | 80015-002 | FDA UDI | Class III | Active |
| CareStation Server | 80433-002 | FDA UDI | Class I | Unknown |
| ASSURE, Garment, Style A, Size 7 | 80015-007 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style B, Size 4 | 80016-004 | FDA UDI | Class III | Active |
| Battery | 80499-003 | FDA UDI | Class II | Active |
| ASSURE Patient Application | 80601-001 | FDA UDI | Class I | Active |
| ASSURE WCD System | 80014-002 | FDA UDI | Class III | Active |
| CareStation Server | 80433-003 | FDA UDI | Class I | Unknown |
| ASSURE WCD System | 80014-001 | FDA UDI | Class III | Active |
| ASSURE Patient Application | 80429-003 | FDA UDI | Class I | Active |
| ASSURE Patient Application | 80315-005 | FDA UDI | Class I | Active |
| ASSURE, Carry Pack | 3326502-003 | FDA UDI | Class III | Active |
| Kestra Provided Device Patient Application | 80740-001 | FDA UDI | Class I | Unknown |
| ASSURE Wearable ECG | 80553-001 | FDA UDI | Class II | Active |
| ASSURE, Garment, Style B, Size 5 | 80016-005 | FDA UDI | Class III | Active |
| ASSURE, Battery | 3322882-005 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style B, Size 1 | 80016-001 | FDA UDI | Class III | Active |
| ASSURE, Monitor | 80008-004 | FDA UDI | Class III | Active |
| System Cable | 80500-003 | FDA UDI | Class II | Active |
| ASSURE, Therapy Cable | 80004-003 | FDA UDI | Class III | Active |
| ASSURE, Charger | 3326633-004 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style B, Size 3 | 80016-003 | FDA UDI | Class III | Active |
| ASSURE, Garment, Style B, Size 6 | 80016-006 | FDA UDI | Class III | Active |
| ASSURE Wearable ECG | K233864 | FDA 510(k) | Class II | Active |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System | P200037 | FDA PMA | Class III | Active |
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