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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 59 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	460-PS-T8	FDA UDI	Class I	Active
Intensa	460-PS-ST	FDA UDI	Class I	Active
Lumex	FR566DGH1323PA	FDA UDI	Class I	Active
Lumex	FR587W454PA	FDA UDI	Class I	Active
Intensa	744B-WW	FDA UDI	Class I	Active
Intensa	748CB-AQ	FDA UDI	Class I	Active
Intensa	IN587WDH8604PA	FDA UDI	Class I	Active
Lumex	FR565TG427	FDA UDI	Class I	Active
Intensa	IN566DGAQ	FDA UDI	Class I	Active
Intensa	IN566DGHPLPA	FDA UDI	Class I	Active
Grafco	4109-1LF	FDA UDI	Class I	Active
Grafco	2642	FDA UDI	Class I	Active
Hausted	4600-DW-OG	FDA UDI	Class I	Active
Intensa	IN566DG1319PA	FDA UDI	Class I	Active
Intensa	IN566GH1311PA	FDA UDI	Class I	Active
Intensa	460-FS-AA-BL	FDA UDI	Class I	Active
Lumex	FR597G8615	FDA UDI	Class I	Active
Lumex	FR587WDH6724	FDA UDI	Class I	Active
Labtron	507LB	FDA UDI	Class I	Active
Intensa	IN566DGH6727PA	FDA UDI	Class I	Active
Gendron	G2420-750	FDA UDI	Class I	Active
Intensa	460-FL-VI	FDA UDI	Class I	Active
Intensa	IN566GHWH	FDA UDI	Class I	Active
Intensa	IN577RGH1323PA	FDA UDI	Class I	Active
Intensa	460-AA-T3	FDA UDI	Class I	Active
Lumex	FR566DGH9207PA	FDA UDI	Class I	Active
Lumex	FR565WG409	FDA UDI	Class I	Active
Intensa	IN587WH1325PA	FDA UDI	Class I	Active
Lumex	FR587WH1305PA	FDA UDI	Class I	Active
Lumex	FR601PH401	FDA UDI	Class I	Active
Everest & Jennings	3H020110	FDA UDI	Class I	Active
Intensa	7408-CB-AQ	FDA UDI	Class I	Active
Intensa	IN566GH1325PA	FDA UDI	Class I	Active
Labtron	510	FDA UDI	Class I	Active
Intensa	620-T3	FDA UDI	Class I	Active
Intensa	IN577RGHAQ	FDA UDI	Class I	Active
Everest & Jennings	3F012320	FDA UDI	Class I	Active
Intensa	IN566DG1304PA	FDA UDI	Class I	Active
Hausted	4600-FS-PS-PL	FDA UDI	Class I	Active
Lumex	LS900MAT48	FDA UDI	Class II	Active
Lumex	FR587WH6717PA	FDA UDI	Class I	Active
Intensa	460-DO	FDA UDI	Class I	Active
Intensa	IN587WHDBPA	FDA UDI	Class I	Active
Everest & Jennings	12023110	FDA UDI	Class I	Active
Hausted	4600-FL-OG	FDA UDI	Class I	Active
Intensa	460-FS-DW-ST	FDA UDI	Class I	Active
Intensa	460-AA-T10	FDA UDI	Class I	Active
Intensa	7408-B-AL	FDA UDI	Class I	Active
Everest & Jennings	907632B2A	FDA UDI	Class I	Active
Lumex	FR565WG454	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.