Identity
- Trade Name
- ASSURE WCD System FDA UDI
- Generic Name
- Wearable defibrillation system defibrillator FDA UDI
- Device Name
- The ASSURE Wearable Cardioverter Defibrillator System FDA UDI
- Model / Reference
- 80014-001 FDA UDI
- Description
- The ASSURE Wearable Cardioverter Defibrillator System FDA UDI
Identifiers
- Catalog Number
- 80014-001 FDA UDI
- Primary DI / UDI-DI
- 00840241600047 FDA UDI
- PMA Number
- P200037 FDA UDI
- FDA Product Code
- MVK FDA UDI
- GMDN Term
- Wearable defibrillation system defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wearable defibrillation system defibrillator
ASSURE WCD System by Kestra Medical Technologies, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable defibrillation system defibrillator.
- Jewel Starter Kit — ELEMENT SCIENCE, INC. · Class III
- Jewel Patch — ELEMENT SCIENCE, INC. · Class III
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") — ELEMENT SCIENCE, INC. · Class III
- ASSURE, Garment, Style A, Size 6 — Kestra Medical Technologies, Inc. · Class III
- ASSURE, Carry Pack — Kestra Medical Technologies, Inc. · Class III
- ASSURE, Garment, Style A, Size 5 — Kestra Medical Technologies, Inc. · Class III
- ASSURE, Garment, Style A, Size 3 — Kestra Medical Technologies, Inc. · Class III
- ASSURE, Tablet — Kestra Medical Technologies, Inc. · Class III
Cleared under the same submission
P200037 also covers:
- ASSURE WCD System — Kestra Medical Technologies, Inc.
- ASSURE, Battery — Kestra Medical Technologies, Inc.
- ASSURE, Carry Pack — Kestra Medical Technologies, Inc.
- ASSURE, Charger — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 1 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 2 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 3 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 4 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 5 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 6 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style A, Size 7 — Kestra Medical Technologies, Inc.
- ASSURE, Garment, Style B, Size 1 — Kestra Medical Technologies, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Kestra Medical Technologies, Inc.
Sources (1)
- FDA UDI 1ec079ac-314d-43ad-a010-9bfca975c2a3 37 fields · synced Jun 9, 2026