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ASSURE WCD System 80014-003

by Kestra Medical Technologies, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840241600375 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ASSURE WCD System
Generic Name
Wearable defibrillation system defibrillator
Model / Ref / Catalog
80014-003
Primary DI / UDI-DI
00840241600375
PMA Number
FDA Product Code
MVK
GMDN Term
Wearable defibrillation system defibrillator
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P200037)

Show all (12)

Other devices from Kestra Medical Technologies, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No