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) (3) Gown, Examination (FME) (1)

Premarket Exempt

No Yes

Clear

HTP1500 Accessory - 10615089311601 Catalog Number : 3116-0001

Device Description : Water Temp / Flow Rate Tester; HTP1500 Pump

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Soft Air - 10615089315005 Catalog Number : 3150-0001

Device Description : Blower

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089315111 Catalog Number : 3151-1005

Device Description : Blower Cart

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089315203 Catalog Number : 3152-0001

Device Description : Standard Replacement Filter

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089315302 Catalog Number : 3153-0001

Device Description : Replacement Filter, HEPA

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089315401 Catalog Number : 3154-0001

Device Description : Replacement Hose, 6 ft.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft Air - 10615089315500 Catalog Number : 3155-0001

Device Description : Hose Hanger

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089620109 Catalog Number : 6201-0001

Device Description : Accessory Hose Set for CSZ Unit

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Soft-Temp - 10615089620208 Catalog Number : 6202-0001

Device Description : Accessory Hose Set for Baxter/Gaymar/Stryker Units

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

ThermalX - 10615089700108 Catalog Number : 7001-0001

Device Description : Small Blanket (infant) 88x100 cm.

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

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