TOMY INTERNATIONAL, INC.

TOMY INTERNATIONAL, INC.

Address:45 Shawmut Rd,Canton,MA,02021,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

Ring, Teething, Fluid-Filled (KKO) (4) Thermometer, Electronic, Clinical (FLL) (4) Pump, Breast, Powered (HGX) (2)

Premarket Exempt

No Yes

Clear

BOON - B268B111850 Catalog Number :

Device Description : BOON Care Health Kit (Thermometer)

Device Class : 2

Duns Number: 065183758

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

LAMAZE/JOHN DEERE - B268L274120 Catalog Number : L27412

Device Description : LAMAZE JD Chill Teether

Device Class :

Duns Number: 065183758

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Lamaze - B268L276190 Catalog Number : L27619

Device Description : Water Filled Chill Teethers

Device Class :

Duns Number: 065183758

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

American Red Cross - B268Y108960 Catalog Number : Y10896

Device Description : Ear Thermometer

Device Class : 2

Duns Number: 065183758

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

The First Years - B268Y52880 Catalog Number :

Device Description : Star Teether

Device Class :

Duns Number: 065183758

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Lamaze - B268Y5288L0 Catalog Number :

Device Description : Teether

Device Class : 2

Duns Number: 065183758

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

The First Years - B268Y60530 Catalog Number :

Device Description : Quiet Expressions Plus Rechargeable Pump - Double

Device Class : 2

Duns Number: 065183758

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

The First Years - B268Y62280 Catalog Number :

Device Description : Quiet Expressions breast pump with Breastflow bottle

Device Class : 2

Duns Number: 065183758

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

The First Years - B268Y70510 Catalog Number :

Device Description : TFY Rapid Read Underarm Thermometer

Device Class : 2

Duns Number: 065183758

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

American Red Cross - B268Y7054Y70570 Catalog Number : Y7057

Device Description : Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)

Device Class : 2

Duns Number: 065183758

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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