Safety 1st

FDA UDI

Class II (US FDA UDI)

by Dorel Juvenile Group, Inc.

Identity

Trade Name: Safety 1st FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: Baby's 1st Sneezes & Wheezes Kit FDA UDI
Model / Reference: IH656 FDA UDI
Description: Baby's 1st Sneezes & Wheezes Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00884392004392 FDA UDI
FDA Product Code: FLL FDA UDI
KYX FDA UDI
KYZ FDA UDI
GMDN Term: Intermittent electronic patient thermometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
880.6430 FDA UDI
880.6960 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent electronic patient thermometer Nasal aspirator, manual Medicine spoon, reusable

Safety 1st by Dorel Juvenile Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medicine spoon, reusable.

Arthroscopy hand instruments — SOPRO-COMEG GmbH · Class II
Nature's Promise — Ahold U.S.A., Inc. · Class I
AESCULAP — AESCULAP, INC. · Class I
AESCULAP — AESCULAP, INC. · Class I
AESCULAP — AESCULAP, INC. · Class I
Biopsy forceps — SOPRO-COMEG GmbH · Class II
Apex — COMPASS HEALTH BRANDS CORP. · Class I
Apex — COMPASS HEALTH BRANDS CORP. · Class I

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dorel Juvenile Group, Inc.

Sources (1)

FDA UDI 078b838c-5d34-472b-9331-d3f37879229f 33 fields · synced May 30, 2026