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) (9) Tube, Tracheal (W/Wo Connector) (BTR) (1)

Premarket Exempt

No Yes

Clear

SourceMark - 00897392002800 Catalog Number :

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

Kozee - 08973920006501 Catalog Number :

Device Description : Torso Warming Blanket Intraoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006518 Catalog Number :

Device Description : Lower Body Warming Blanket Intraoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006525 Catalog Number :

Device Description : Upper Body Warming Blanket Intraoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006532 Catalog Number :

Device Description : Adult Full Body Warming Blanket Postoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006549 Catalog Number :

Device Description : Under Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006556 Catalog Number :

Device Description : Full Access Under Body Warming Blanket

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006563 Catalog Number :

Device Description : Full Body Warming Blanket Postoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006570 Catalog Number :

Device Description : Full Body Surgical Warming Blanket Postoperative

Device Class : 2

Duns Number: 121225812

Premarket Exempt : No

Product Code : DWJ

Prescription Use : No

Device Count : 1

Kozee - 08973920006587 Catalog Number :

Device Description : Large 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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