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Giraffe and Panda Warmers

by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. 2 variants

510(k) K101804

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101804↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK101804 Date21 Jul 2010ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

5 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0481-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0482-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0483-2019 FDA Class II initiated 25 Sep 2018
    • Terminated Z-0484-2019 FDA Class II initiated 25 Sep 2018

    Potential electric leakage affecting the user.

    • Terminated Z-1072-2014 FDA Class I initiated 1 Oct 2013 on shared 510(k) K101804

    Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FMT
Device Class
Class II
Regulation
21 CFR Part 880.5130
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Giraffe and Panda Warmers are Infant Radiant Warmers, designed to provide controlled infrared heat for neonates who cannot regulate their own body temperature. These devices maintain thermal stability in vulnerable infants by delivering precise, radiant warmth to prevent hypothermia and support physiological stability during critical care.

These warmers are intended for use in general hospital settings, supplied as single-use or reusable devices (as indicated by the product codes and regulatory submissions). They comply with FDA 510(k) clearance under regulation 880.5130 and are classified as Class II medical devices. Sterility and MRI safety are not specified in the available data, but they are regulated under MDR and FDA 510K authorisations.

Other devices from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.