FDA.reportPublic FDA data

ASSURE WCD System

Primary DI
00840241600375
Brand
ASSURE WCD System
Company
Kestra Medical Technologies, Inc.
Model
80014-003
Catalog number
80014-003
Device description
The ASSURE Wearable Cardioverter Defibrillator System
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVKWearable Automated External Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVKWearable Automated External DefibrillatorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200037000
P200037018

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200037000ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.2021-07-27MVK
P200037018ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.2021-07-27MVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840241600238PreviousGS10
00840241600375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840241600238008402416002388402416002380840241600238
00840241600375008402416003758402416003750840241600375

GMDN Terms#

Term, Definition table
TermDefinition
Wearable defibrillation system defibrillatorA portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1.833.692.7787xx@xx.xx

Regulatory Flags#

DUNS number
060944361
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840241600405ASSURE, Monitor80008-00580008-0052026-04-15
00840241600412Kestra Provided Device Patient Application80740-01080740-0102026-02-04
00840241600399Kestra Provided Device Patient Application80740-00580740-0052025-04-30
00840241600382Kestra Provided Device Patient Application80740-00180740-0012024-09-18
00840241600313ASSURE Wearable ECG80553-00180553-0012024-09-18
00840241600320Battery 80499-00380499-0032024-09-18
00840241600337System Cable80500-00380500-0032024-09-18
00840241600344ASSURE Assist Service80739-00180739-0012024-09-18
00840241600238ASSURE WCD System80014-00280014-0022023-06-26
00840241600283ASSURE Patient Application80601-001 80601-001 2023-03-13
00840241600306CareStation Server80605-00480605-0042023-03-12
00840241600290CareStation Server80605-00380605-0032023-02-12
00840241600276CareStation Server80433-00380433-0032023-02-10
00840241600221ASSURE, Monitor80008-00480008-0042022-12-09
00840241600245ASSURE, Tablet80041-00280041-0022022-12-09
00840241600269CareStation Server80433-00280433-0022022-06-10
00840241600252ASSURE Patient Application80429-00380429-0032022-06-24
00840241600009ASSURE, Battery 3322882-0053322882-0052021-11-15
00840241600016ASSURE, Charger3326633-0043326633-0042021-11-15
00840241600023ASSURE, Therapy Cable80004-00380004-0032021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047782052Jewel Mobile AppElement Science, Inc.MVK2026-05-04
00850047782168Jewel Mobile AppElement Science, Inc.MVK2026-05-04
00840241600405ASSURE, MonitorKestra Medical Technologies, Inc.MVK2026-04-15
00850047782007"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")"Element Science, Inc.MVK2025-05-12
00850047782038Jewel Starter KitElement Science, Inc.MVK2025-05-12
00850047782090Jewel PatchElement Science, Inc.MVK2025-05-12
00855778005432LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-21
00855778005449LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-21
00855778005371LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005388LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005395LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005401LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00840241600238ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2023-06-26
00840241600221ASSURE, MonitorKestra Medical Technologies, Inc.MVK2022-12-09
00840241600245ASSURE, TabletKestra Medical Technologies, Inc.MVK2022-12-09
00840241600009ASSURE, Battery Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600016ASSURE, ChargerKestra Medical Technologies, Inc.MVK2021-11-15
00840241600023ASSURE, Therapy CableKestra Medical Technologies, Inc.MVK2021-11-15
00840241600030ASSURE, MonitorKestra Medical Technologies, Inc.MVK2021-11-15
00840241600047ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2021-11-15
00840241600054ASSURE, Garment, Style A, Size 1Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600061ASSURE, Garment, Style A, Size 2Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600078ASSURE, Garment, Style A, Size 3Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600085ASSURE, Garment, Style A, Size 4Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600092ASSURE, Garment, Style A, Size 5Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600108ASSURE, Garment, Style A, Size 6Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600115ASSURE, Garment, Style A, Size 7Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600122ASSURE, Garment, Style B, Size 1Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600139ASSURE, Garment, Style B, Size 2Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600146ASSURE, Garment, Style B, Size 3Kestra Medical Technologies, Inc.MVK2021-11-15