ADROIT MEDICAL SYSTEMS, INC.

Address:1146 CARDING MACHINE RD.,LOUDON,TN,37774,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

System, Thermal Regulating (DWJ) (10)

Premarket Exempt

Yes No

Clear

Soft Air - 10615089181006 Catalog Number : 1810-0001

Device Description : Blanket, Underbody Infant, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089181105 Catalog Number : 1811-0001

Device Description : Blanket, Full Underbody, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089185103 Catalog Number : 1851-0001

Device Description : Blanket, Full Body, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089185202 Catalog Number : 1807-0001

Device Description : Blanket, Upper Body, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089185301 Catalog Number : 1853-0001

Device Description : Blanket, Lower Body, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089185400 Catalog Number : 1854-0001

Device Description : Blanket, Full Body, Pediatric, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089185608 Catalog Number : 1856-0001

Device Description : Blanket, Torso, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089185707 Catalog Number : 1857-0001

Device Description : Blanket, Torso 2-Port, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089186001 Catalog Number : 1820-0001

Device Description : Blanket, Underbody, Infant, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089186100 Catalog Number : 1861-0001

Device Description : Blanket, Underbody, Pediatric, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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