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Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

by Ohmeda Medical

510(k) K072157

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Special NumberK072157 Date27 Aug 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1507-2017 FDA Class II initiated 18 Nov 2016

    Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 25 Sep 2026

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

This device is a modification to Giraffe and Panda warmers, incorporating an uninterruptible power supply (UPS) for temporary battery-backed operation during power failure or intra-hospital transport. It is designed to maintain thermal regulation and support infant care in clinical settings.

The modification is used in hospitals by trained clinicians and provides output including thermal regulation, SpO2/pulse rate data, and resuscitation support. It enables intra-hospital mobility with short-term battery power to ensure a stable thermal and oxygen environment for vulnerable infants. The device is supplied as a component for use with Giraffe and Panda warmers and is authorized under FDA 510(k) clearance K072157.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the purpose of the modification to Giraffe and Panda warmers?

    The modification incorporates an uninterruptible power supply (UPS) to provide temporary battery-backed operation during power failure or intra-hospital transport, ensuring continuous thermal regulation and support for infant care in clinical settings.

  • How is the UPS modification supplied for use with Giraffe and Panda warmers?

    The device is supplied as a component designed for use with Giraffe and Panda warmers, integrating directly with these systems to provide backup power and maintain functionality during power interruptions or transport within a hospital.

  • Is the modification to Giraffe and Panda warmers intended for single-use or reuse?

    The modification is designed for reuse as a component of the Giraffe and Panda warmer systems, providing ongoing battery-backed operation capability during power failures or intra-hospital transport when attached to the warmer.