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

No Yes

Clear

Soft Air - 10615089195409 Catalog Number : 1904-0001

Device Description : Blanket, Full Body Pediatric

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089195607 Catalog Number : 1911-0001

Device Description : Blanket, Torso

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089195706 Catalog Number : 1914-0001

Device Description : Blanket, Torso 2-Port

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089196000 Catalog Number : 1908-0001

Device Description : Blanket, Underbody, Infant

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089196109 Catalog Number : 1906-0001

Device Description : Blanket, Underbody, Pediatric

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089196208 Catalog Number : 1907-0001

Device Description : Blanket, Full Underbody

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089196307 Catalog Number : 1905-0001

Device Description : Blanket, Full Underbody, Full Access

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089197007 Catalog Number : 1970-0001

Device Description : Blanket, Multi-Access

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089197106 Catalog Number : 1971-0001

Device Description : Blanket, Multi-Access, Surgical

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089197205 Catalog Number : 1915-0001

Device Description : Blanket, Surgical Access

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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