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Summer Infant

FDA UDI

Class II (US FDA UDI)

by Summer Infant (usa), Inc.

Identity

Trade Name
Summer Infant FDA UDI
Generic Name
Infant care kit FDA UDI
Device Name
Complete Nursery Care Kit - Neutral (Stick & Forehead strip) FDA UDI
Model / Reference
14464 FDA UDI
Description
Complete Nursery Care Kit - Neutral (Stick & Forehead strip) FDA UDI

Identifiers

Primary DI / UDI-DI
00012914144640 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Infant care kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Liquid Chemical FDA UDI

Category: Infant care kit

Summer Infant by Summer Infant (usa), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infant care kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 75de12d6-4ea2-4b78-9de5-48a2892245b0 35 fields · synced May 30, 2026