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

Gown, Examination (FME) (10)

Premarket Exempt

No Yes

Clear

ThermalX - 10615089700207 Catalog Number : 7002-0001

Device Description : Medium Blanket 120x120cm

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089700306 Catalog Number : 7003-0001

Device Description : Large Blanket 120x210cm

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089700405 Catalog Number : 7004-0001

Device Description : Neonatal Cap

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089700504 Catalog Number : 7005-0001

Device Description : Infant Cap

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089700702 Catalog Number : 7007-0001

Device Description : Youth Cap

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089700801 Catalog Number : 7008-0001

Device Description : Adult Cap

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089700900 Catalog Number : 7009-0001

Device Description : Jacket Medium, with Silver Arms

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089701204 Catalog Number : 7012-0001

Device Description : Jacket Medium, All Silver

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089701303 Catalog Number : 7013-0001

Device Description : Jacket Large, All Silver

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ThermalX - 10615089701402 Catalog Number : 7014-0001

Device Description : Small Pulse Oximetry Mitt

Device Class : 1

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

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