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Giraffe Panda Disposable Skin Temperature

FDA UDI

Class II (US FDA UDI)

by Datex-Ohmeda Inc.

Identity

Trade Name
GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
GIRAFFE PANDA DISPOSABLE INFANT SKIN TEMPERATUR PROBE FDA UDI
Model / Reference
NA FDA UDI
Description
GIRAFFE PANDA DISPOSABLE INFANT SKIN TEMPERATUR PROBE FDA UDI

Identifiers

Primary DI / UDI-DI
00195278358363 FDA UDI
510(k) Number
K123309 FDA UDI
K152809 FDA UDI
K152814 FDA UDI
K201628 FDA UDI
FDA Product Code
FMZ FDA UDI
FMT FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5400 FDA UDI
880.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: General-purpose patient temperature probe, single-use

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

Similar devices

Also classified as General-purpose patient temperature probe, single-use.

Cleared under the same submission

K123309 also covers:

K152809 also covers:

K201628 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Datex-Ohmeda Inc.

Sources (1)

  • FDA UDI f357c676-97a1-448a-bc21-c0a045d77595 35 fields · synced May 30, 2026