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) (6) System, Thermal Regulating (DWJ) (4)

Premarket Exempt

No Yes

Clear

Soft Air - 10615089197304 Catalog Number : 1916-0001

Device Description : Blanket, Cardiac Access

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089198004 Catalog Number : 1980-0001

Device Description : Blanket, Pediatric Tube

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089198103 Catalog Number : 1909-0001

Device Description : Blanket, Cath Lab Tube

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089199001 Catalog Number : 1990-0001

Device Description : Standard Gown, Adult

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

HTP1500 - 10615089310109 Catalog Number : HTP1500

Device Description : Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free

Device Class : 2

Duns Number: 795104769

Premarket Exempt : No

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Surface Warming & Cooling System - 10615089310208 Catalog Number : 3102-0001

Device Description : Surface Warming & Cooling System

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Accessory; HTP1500 - 10615089310307 Catalog Number : 3103-0001

Device Description : IV Pole Bracket for HTP1500

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Mobile Ice - 10615089310505 Catalog Number : 3105-0001

Device Description : Portable Motorized Cold Therapy Unit

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Accessory; HTP1500 Bed Bracket - 10615089310901 Catalog Number : 3109-0001

Device Description : Bed Bracket for HTP1500 Pump

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

HTP1500 - 10615089311106 Catalog Number : 3111-0001

Device Description : Accessory Rolling Stand for HTP1500 Pump

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

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