HOMEDICS USA, LLC

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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

Oximeter (DQA) (1) Pad, Heating, Powered (IRT) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

HoMedics - 00031262099280 Catalog Number : PX-132-HP

Device Description : Pulse Oximeter

Device Class :

Duns Number: 164414364

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

HOMEDICS - 00031262101242 Catalog Number :

Device Description : Infrared Ear/Forehead Thermometer

Device Class :

Duns Number: 164414364

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101730 Catalog Number :

Device Description : PILLOW WITH REMOVEABLE GEL

Device Class : 2

Duns Number: 164414364

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

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