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

Pack, Hot Or Cold, Water Circulating (ILO) (10)

Premarket Exempt

No Yes

Clear

Soft-Temp - 10615089106009 Catalog Number : ST-060

Device Description : Blanket Adult 24x60 in. (Filled Dimensions); Hyper-Hypothermia Non-Woven Fabric Blanket Adult 24x60 in. (Filled Dimensions); Hyper-Hypothermia Non-Woven Fabric Both Sides; Latex/PVC Free; Disposable.

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089107006 Catalog Number : ST-900

Device Description : Cool Kit w/Head Wrap, Patient Vest and Blanket Wrap for Legs

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089109109 Catalog Number : 1091-0001

Device Description : Accessory Thermometer for Temp Probe Adapter Cable Esophageal Rectal Probe

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Soft-Temp - 10615089111706 Catalog Number : WD-017

Device Description : Pad Heat Small 12x17 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089112000 Catalog Number : WD-020

Device Description : Pad Heat Medium 14x20 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089112406 Catalog Number : WD-024

Device Description : Pad Heat Large 18x24in (Filled Dimensions) All Polymer Latex/PVC Free Disposable.

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089113007 Catalog Number : WD-030

Device Description : Blanket Pediatric 24x30 in. (Filled Dimensions) Hyper-Hypothermia All Polymer La Blanket Pediatric 24x30 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free Disposable

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089116008 Catalog Number : WD-060

Device Description : Blanket Adult 24x60 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/ Blanket Adult 24x60 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free disposable.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089121200 Catalog Number : ST-212

Device Description : Pad for Motorized Cold Therapy Unit Shoulder Non-Sterile 12x12in w/straps.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089121705 Catalog Number : ST-217

Device Description : Pad Heat Small 12x17in (Filled Dimensions) Non-Woven Medium Weight Fabric Both S Pad Heat Small 12x17in (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

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