Datex Ohmeda, Inc. dba GE Healthcare

All lots.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: The devices were widely distributed to national and international medical facilities.

Giraffe OmniBed¿, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. || The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.

Serial Numbers: SBE07014189PA SBE07014184PA SBE07014167PA SBE06524133PA SBE07014196PA SBE07024243PA SBE07034259PA SBE07024238PA SBE07034256PA SBE07024218PA SBE07034268PA SBE07024212PA SBE07054323PA SBE07064333PA SBE07064354PA SBE07034248PA SBE07024229PA SBE07024211PA SBE07024239PA SBE07024237PA SBE07024203PA SBE07064387PA SBE07064335PA SBE07064395PA SBE07014187PA SBE07024225PA SBE07024227PA SBE07014181PA SBE07024204PA SBE07024206PA SBE07034313PA SBE07044317PA SBE07034261PA SBE07024231PA SBE07034276PA SBE07064357PA SBE07024219PA SBE07014194PA SBE07044315PA SBE07024201PA SBE07024215PA SBE07034302PA SBE07034252PA SBE07014179PA SBE07034247PA SBE07034246PA SBE07014152PA SBE07024244PA SBE07014191PA SBE07034298PA SBE07034299PA SBE07024241PA SBE07044322PA SBE07024216PA SBE07044318PA SBE07024213PA SBE07044316PA SBE07034260PA SBE07064375PA SBE07064398PA SBE07064368PA SBE07064377PA SBE07064373PA SBE07064341PA SBE07064384PA SBE07034255PA SBE07064347PA SBE07014185PA SBE07024208PA SBE07024214PA SBE07024205PA SBE07024207PA SBE07064389PA SBE07064330PA SBE07064352PA SBE07034250PA SBE07034257PA SBE07034254PA SBE07044321PA SBE07024242PA SBE07024235PA SBE07034270PA SBE07034264PA SBE07024220PA SBE07024236PA SBE06514069PA SBE06514079PA SBE06514078PA SBE06514081PA SBE06514092PA SBE06514084PA SBE06514090PA SBE07014199PA SBE07064385PA SBE07064390PA SBE07064393PA SBE07064331PA SBE07014200PA SBE07064369PA SBE07024232PA SBE07034296PA SBE07064340PA SBE07034307PA SBE07034309PA SBE07064353PA SBE07034301PA SBE07034310PA SBE07034300PA SBE07034306PA SBE07034308PA SBE07044319PA SBE07034312PA SBE07034304PA SBE07014166PA SBE07034272PA SBE07034281PA SBE07034290PA SBE07034291PA SBE07054324PA SBE07064329PA SBE07034280PA SBE07064334PA SBE07064336PA SBE07024240PA SBE07034251PA SBE07034267PA SBE07034293PA SBE07034279PA SBE07034274PA SBE07034258PA SBE07064345PA SBE07034286PA SBE07034295PA

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution.

Corometrics¿ MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. || Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02.

Serial numbers: HEBE50008 - HEBE50019;  HEBF50001 - HEBF50311;  HEBG50001 - HEBG50751;  HEBH50001 - HEBH50950;  HEBJ50000 - HEBJ50432;  HEBG54001 - HEBG54035;  HEBH54001 - HEBH54999; HEBH55000 - HEBH55041;  HEBJ55033 - HEBJ55036;

General Hospital and Personal Use Devices

2

No

Product was distributed to medical facilities in the US and international subsidiaries and distributors.

Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System