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GF Health Products, Inc

United States·US-MF-000002167

Last updated September 17, 2026

Information

Country: United States
Address: One Graham Field Way, Atlanta, United States
Website: www.grahamfield.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +17703684700
PRRC Contact: Amy Piccini
EUDAMED SRN: US-MF-000002167
FDA FEI Number: 2427360
DUNS Number: —

Catalogue (4538)

Page 3 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR577RG8615PA	FDA UDI	Class I	Active
Hausted	6200DA-VI	FDA UDI	Class I	Active
John Bunn	JB0112-070	FDA UDI	Class II	Active
Hausted	4200-SH	FDA UDI	Class I	Active
Everest & Jennings	20252418B	FDA UDI	Class I	Active
Lumex	FR597P8615	FDA UDI	Class I	Active
Intensa	748-PM	FDA UDI	Class I	Active
Hausted	ESC2EYEST-MB	FDA UDI	Class I	Active
Intensa	744B-BL	FDA UDI	Class I	Active
Intensa	IN587WDMOPA	FDA UDI	Class I	Active
Grafco	3395-2	FDA UDI	Class I	Active
Intensa	IN577RG1315	FDA UDI	Class I	Active
Everest & Jennings	90763030A	FDA UDI	Class I	Active
Intensa	420-EO-WG	FDA UDI	Class I	Active
Labtron	602L	FDA UDI	Class I	Active
Intensa	IN566GHAR	FDA UDI	Class I	Active
Intensa	IN597G8584	FDA UDI	Class I	Active
Intensa	7408-CB-AL	FDA UDI	Class I	Active
Basic American Medical Products	MZ6AF42	FDA UDI	Class II	Active
Everest & Jennings	8100206	FDA UDI	Class I	Active
Grafco	9677BL	FDA UDI	Class I	Active
Intensa	IN566GDO	FDA UDI	Class I	Active
Intensa	460-AA-SH	FDA UDI	Class I	Active
Intensa	460-PS-MO	FDA UDI	Class I	Active
Intensa	IN587WDPLPA	FDA UDI	Class I	Active
Intensa	744CB-T9	FDA UDI	Class I	Active
Intensa	IN577RGH6724PA	FDA UDI	Class I	Active
Everest & Jennings	90763004A	FDA UDI	Class I	Active
Lumex	FR565WG8805	FDA UDI	Class I	Active
Lumex	LCM4280	FDA UDI	Class II	Active
Intensa	IN597P9205	FDA UDI	Class I	Active
Intensa	7408-B-WH	FDA UDI	Class I	Active
Hausted	4600-AA-FS-TE	FDA UDI	Class I	Active
Intensa	420-EO-T3	FDA UDI	Class I	Active
Intensa	IN587WDHNO	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRBLUE	FDA UDI	Class I	Active
Intensa	460-FS-DW-MO	FDA UDI	Class I	Active
Lumex	FR577RGH1304	FDA UDI	Class I	Active
Intensa	IN587WDWGPA	FDA UDI	Class I	Active
Intensa	IN577RGH6727PA	FDA UDI	Class I	Active
Hausted	4200-EO-PU	FDA UDI	Class I	Active
Lumex	FR587WH1304PA	FDA UDI	Class I	Active
Intensa	IN566DG6714	FDA UDI	Class I	Active
Intensa	IN587WDH1304	FDA UDI	Class I	Active
Lumex	89180	FDA UDI	Class I	Active
Lumex	FR587WH427PA	FDA UDI	Class I	Active
Lumex	FR587WH401	FDA UDI	Class I	Active
Labtron	1227-3	FDA UDI	Class II	Active
Lumex	FR597P409	FDA UDI	Class I	Active
Intensa	IN587WH1304	FDA UDI	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 24, 2021	Z-1353-2021	—	terminated	The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
Sep 30, 2016	Z-0732-2017	—	terminated	GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.
Sep 14, 2009	Z-0139-2010	—	terminated	Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.