Smart Care

FDA UDI

Class I (US FDA UDI)

by Ashtel Studios, Inc.

Identity

Trade Name: Smart Care FDA UDI
Generic Name: Infant care kit FDA UDI
Device Name: Fisher-Price Healthcare Kit 6pcs: 1 x medicine dropper, 1 x medicine spoon, 1 x digital thermometer, 1 x nasal aspirator, 1 x emergency card, 1 nail clipper FDA UDI
Model / Reference: 84232-24 FDA UDI
Description: Fisher-Price Healthcare Kit 6pcs: 1 x medicine dropper, 1 x medicine spoon, 1 x digital thermometer, 1 x nasal aspirator, 1 x emergency card, 1 nail clipper FDA UDI

Identifiers

Primary DI / UDI-DI: 00850010842325 FDA UDI
FDA Product Code: KYX FDA UDI
GCY FDA UDI
FLL FDA UDI
GMDN Term: Infant care kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6430 FDA UDI
878.4680 FDA UDI
880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infant care kit

Smart Care by Ashtel Studios, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ashtel Studios, Inc.

Sources (1)

FDA UDI cbbbfa20-f9cb-4bd5-97c1-def148d8fb90 33 fields · synced Jun 1, 2026