Giraffe

FDA UDI

Class II (US FDA UDI)

by Datex-Ohmeda Inc.

Identity

Trade Name: Giraffe FDA UDI
Generic Name: Infant warmer FDA UDI
Device Name: GIRAFFE WARMER FDA UDI
Model / Reference: Warmer FDA UDI
Description: GIRAFFE WARMER FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682103923 FDA UDI
510(k) Number: K101804 FDA UDI
K122267 FDA UDI
K123309 FDA UDI
K201628 FDA UDI
FDA Product Code: FMT FDA UDI
GMDN Term: Infant warmer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5130 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

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infant warmer

Giraffe by Datex-Ohmeda Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infant warmer.

HEATING ELEMENT 350W-120V — RPI · Class II
HEATING ELEMENT 440W-104V — RPI · Class II
HEATER — RPI · Class II
ADVANCED INFANT WARMER — ADVANCED INSTRUMENTATIONS, INC. · Class II
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
NuBorne Infant Warmer — INTERNATIONAL BIOMEDICAL, LTD. · Class II
Olympic Warm-Lamps — Natus Medical Incorporated · Class II
HEATING ELEMENT 741W-120V — RPI · Class II

Cleared under the same submission

K101804 also covers:

Giraffe — Datex-Ohmeda Inc.
Panda — Datex-Ohmeda Inc.

K122267 also covers:

Panda — Datex-Ohmeda Inc.

K123309 also covers:

GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE — Datex-Ohmeda Inc.
Panda — Datex-Ohmeda Inc.
Panda — Datex-Ohmeda Inc.
Panda — Datex-Ohmeda Inc.
Panda — Datex-Ohmeda Inc.

K201628 also covers:

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

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Manufacturer

Manufacturer: Datex-Ohmeda Inc.

Sources (1)

FDA UDI 38731136-4997-436a-a20a-f0b1b1ed880a 36 fields · synced May 30, 2026