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KESTRA Medical Technologies, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151853443015185344KESTRA Medical Technologies, Inc.1N2026-01-013933 Lake Washington Blvd, NE Kirkland WA US 98033

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840241600313ASSURE Wearable ECG - A wearable cardiac episode recorder1.833.692.7787xx@xx.xx
00840241600320Battery - A rechargeable battery that powers the ASSURE Wearable ECG1.833.692.7787xx@xx.xx
00840241600375ASSURE WCD System - The ASSURE Wearable Cardioverter Defibrillator System1.833.692.7787xx@xx.xx
00840241600405ASSURE, Monitor - A part of the ASSURE System that provides power and displays system status information1.833.692.7787xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2952201839473574P200037ASSURE Wearable Cardioverter Defibrillator (WCD) SystemMVK2021-07-27
2952201556758142K233864ASSURE Wearable ECGMWJ2024-05-07
2952201139812156
2952201170860655

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWJ12024-05-07
MVK 12021-07-27

PMA#

PMN#

GUDID#

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