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) (6) Pack, Hot Or Cold, Water Circulating (ILO) (4)

Premarket Exempt

No Yes

Clear

Soft-Temp - 10615089122009 Catalog Number : ST-220

Device Description : Pad Heat Medium 14x20in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Pad Heat Medium 14x20in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089122405 Catalog Number : ST-224

Device Description : Pad Heat Large 18x24in (Filled Dimensions) Non-Woven Medium Weight Fabric Both S Pad Heat Large 18x24in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089123006 Catalog Number : ST-230

Device Description : Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free disposable.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089126007 Catalog Number : ST-260

Device Description : Blanket Adult 24x60in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Wei Blanket Adult 24x60in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089180108 Catalog Number : 1801-0001

Device Description : Blanket, Adult, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089180207 Catalog Number : 1802-0001

Device Description : Blanket, Upper Body, Reflective, White

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089180306 Catalog Number : 1803-0001

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 - 10615089180405 Catalog Number : 1804-0001

Device Description : Blanket, Pediatric, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089180504 Catalog Number : 1805-0001

Device Description : Blanket, Half Upper Body, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089180702 Catalog Number : 1805-0001

Device Description : Blanket, Neonatal, Reflective

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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