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

Wearable Automated External Defibrillator (MVK) (10)

Premarket Exempt

Yes No

Clear

ASSURE, Garment, Style A, Size 6 - 00840241600108 Catalog Number : 80015-006

Device Description : The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 6, 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 7 - 00840241600115 Catalog Number : 80015-007

Device Description : The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 7, 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 B, Size 1 - 00840241600122 Catalog Number : 80016-001

Device Description : The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style B, 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 B, Size 2 - 00840241600139 Catalog Number : 80016-002

Device Description : The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style B, 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 B, Size 3 - 00840241600146 Catalog Number : 80016-003

Device Description : The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style B, 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 B, Size 4 - 00840241600153 Catalog Number : 80016-004

Device Description : The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style B, 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 B, Size 5 - 00840241600160 Catalog Number : 80016-005

Device Description : The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style B, 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

ASSURE, Garment, Style B, Size 6 - 00840241600177 Catalog Number : 80016-006

Device Description : The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 6, 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 B, Size 7 - 00840241600184 Catalog Number : 80016-007

Device Description : The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 7, 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, Tablet - 00840241600191 Catalog Number : 80041-001

Device Description : An electronic device used to program the ASSURE system and assist in patient fit An electronic device used to program the ASSURE system and assist in patient fitting and training

Device Class : 3

Duns Number: 060944361

Premarket Exempt : No

Product Code : MVK

Prescription Use : Yes

Device Count : 1

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