Kestra Medical Technologies, Inc.

Address:3933 Lake Washington Blvd, NE,Kirkland,WA,98033,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Medical Device Data System (OUG) (3) Wearable Automated External Defibrillator (MVK) (1)

Premarket Exempt

No Yes

Clear

ASSURE, Carry Pack - 00840241600207 Catalog Number : 3326502-003

Device Description : A portable case that holds the Monitor while wearing the ASSURE system

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : No

Device Count : 1

ASSURE Patient Application - 00840241600214 Catalog Number : 80315-005

Device Description : ASSURE patient app is a component of the ASSURE WCD System and transmits informa ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation

Device Class : 1

Duns Number: 060944361

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

ASSURE Patient Application - 00840241600252 Catalog Number : 80429-003

Device Description : ASSURE patient app is a component of CareStation.

Device Class : 1

Duns Number: 060944361

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

CareStation Server - 00840241600269 Catalog Number : 80433-002

Device Description : CareStation Server acquires and displays data from the WCD for clinicians to view.

Device Class : 1

Duns Number: 060944361

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

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