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) (10)

Premarket Exempt

No Yes

Clear

Kozee - 08973920006594 Catalog Number :

Device Description : Spinal Under Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006600 Catalog Number :

Device Description : Lower Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006617 Catalog Number :

Device Description : Long Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006624 Catalog Number :

Device Description : Cath Lab Warming Blanket Other

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006631 Catalog Number :

Device Description : Surgical Access Warming Blanket Other

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006648 Catalog Number :

Device Description : Cardiac Access Warming Blanket Other

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006655 Catalog Number :

Device Description : XL Upper Body Warming Blanket Intraoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006662 Catalog Number :

Device Description : Full Body & Under Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006679 Catalog Number :

Device Description : Infant Under Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006686 Catalog Number :

Device Description : Lithotomy&Orthopedic Under Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

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