I PLAY. 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

Ring, Teething, Fluid-Filled (KKO) (4) Apparatus, Suction, Single Patient Use, Portable, Nonpowered (GCY) (2) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Green Sprouts - 00715418174730 Catalog Number :

Device Description : Cool Ring Teether (2 pack) Clear - 6mo+

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418176055 Catalog Number :

Device Description : Digital Thermometer-Green-Adult Use Only

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : FLL

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418176826 Catalog Number :

Device Description : Sprout Ware® Nasal Aspirator made from Plants and Silicone-Bulb-Green-Adult Use Only

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : GCY

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418176833 Catalog Number :

Device Description : Sprout Ware® Nasal Aspirator made from Plants and Silicone-Tube-Green-Adult Use Only

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : GCY

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418178998 Catalog Number :

Device Description : Cool Nature Teether - Green/Aqua Set

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418179001 Catalog Number :

Device Description : Cool Nature Teether - Yellow/Aqua Set

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418179889 Catalog Number :

Device Description : Cool Nature Teether - Assorted

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

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