Kestra Medical Technologies, Inc.

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

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Filters

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

Wearable Automated External Defibrillator (MVK) (10)

Premarket Exempt

No Yes

Clear

ASSURE, Battery - 00840241600009 Catalog Number : 3322882-005

Device Description : A rechargeable battery that powers the ASSURE System

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Charger - 00840241600016 Catalog Number : 3326633-004

Device Description : A separate device that charges the Battery

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Therapy Cable - 00840241600023 Catalog Number : 80004-003

Device Description : Provides the connection between the Garment and the Monitor

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Monitor - 00840241600030 Catalog Number : 80008-003

Device Description : A part of the ASSURE System that provides power and displays system status information

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE WCD System - 00840241600047 Catalog Number : 80014-001

Device Description : The ASSURE Wearable Cardioverter Defibrillator System

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Garment, Style A, Size 1 - 00840241600054 Catalog Number : 80015-001

Device Description : The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Garment, Style A, Size 2 - 00840241600061 Catalog Number : 80015-002

Device Description : The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Garment, Style A, Size 3 - 00840241600078 Catalog Number : 80015-003

Device Description : The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Garment, Style A, Size 4 - 00840241600085 Catalog Number : 80015-004

Device Description : The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

ASSURE, Garment, Style A, Size 5 - 00840241600092 Catalog Number : 80015-005

Device Description : The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

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