SOURCEMARK, LLC.

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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

System, Thermal Regulating (DWJ) (5)

Premarket Exempt

No Yes

Clear

Kozee - 08973920006693 Catalog Number :

Device Description : Small Warming Suit

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006709 Catalog Number :

Device Description : Medium Warming Suit

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006716 Catalog Number :

Device Description : Large Warming Suit

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006723 Catalog Number :

Device Description : Extra Large Warming Suit

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006730 Catalog Number :

Device Description : Warming Unit

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

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