SUMMER INFANT (USA), INC.

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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

Thermometer, electronic, clinical (FLL) (6)

Premarket Exempt

Clear

Summer Infant - 00012914143742 Catalog Number :

Device Description : Ear Thermometer & Stick

Device Class : 2

Duns Number: 930830141

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Summer Infant - 00012914144442 Catalog Number :

Device Description : Health and Grooming Kit (Stick)

Device Class : 2

Duns Number: 930830141

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Summer Infant - 00012914144541 Catalog Number :

Device Description : Health and Grooming Kit (Stick)

Device Class : 2

Duns Number: 930830141

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Summer Infant - 00012914144640 Catalog Number :

Device Description : Complete Nursery Care Kit - Neutral (Stick & Forehead strip)

Device Class :

Duns Number: 930830141

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Summer Infant - 00012914144749 Catalog Number :

Device Description : Complete Nursery Care Kit - Neutral (Stick & Forehead strip)

Device Class : 2

Duns Number: 930830141

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Summer Infant - 00012914145142 Catalog Number :

Device Description : Pacifier Thermometer

Device Class : 2

Duns Number: 930830141

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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