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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 31 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN566DGH6714	FDA UDI	Class I	Active
Lumex	FR587WDH432PA	FDA UDI	Class I	Active
Everest & Jennings	8565208	FDA UDI	Class I	Active
Intensa	748CB-AR	FDA UDI	Class I	Active
Lumex	FR587WH8615PA	FDA UDI	Class I	Active
Lumex	FR587WD1325PA	FDA UDI	Class I	Active
Intensa	IN601PHNA	FDA UDI	Class I	Active
Intensa	IN577RGH454PA	FDA UDI	Class I	Active
Everest & Jennings	90763032A	FDA UDI	Class I	Active
LabTron	202	FDA UDI	Class II	Active
Intensa	IN587W8516PA	FDA UDI	Class I	Active
Intensa	IN587WDH432	FDA UDI	Class I	Active
Lumex	FR587WDH432	FDA UDI	Class I	Active
Lumex	GF1840-2	FDA UDI	Class I	Active
Intensa	460-FS-AQ	FDA UDI	Class I	Active
Lumex	FR577RGHO427	FDA UDI	Class I	Active
Intensa	IN601UHAQ	FDA UDI	Class I	Active
Gendron	GS4842SD	FDA UDI	Class II	Active
Lumex	FR597G1323	FDA UDI	Class I	Active
Intensa	460-FL-SH	FDA UDI	Class I	Active
Intensa	IN587W6717	FDA UDI	Class I	Active
Everest & Jennings	3H020350	FDA UDI	Class I	Active
Everest & Jennings	3H021230	FDA UDI	Class I	Active
Lumex	FR566DGH8615PA	FDA UDI	Class I	Active
Lumex	FR587WDHO427PA	FDA UDI	Class I	Active
Intensa	IN577RGHBT	FDA UDI	Class I	Active
Intensa	IN587WD1323	FDA UDI	Class I	Active
Lumex	FR566GHO427	FDA UDI	Class I	Active
Everest & Jennings	8940220	FDA UDI	Class I	Active
Lumex	FR587W432PA	FDA UDI	Class I	Active
Intensa	IN566DGH432	FDA UDI	Class I	Active
Hausted	4200-DW-MO	FDA UDI	Class I	Active
Lumex	FR577RGH9524	FDA UDI	Class I	Active
Intensa	IN577RG1311PA	FDA UDI	Class I	Active
Grafco	2675	FDA UDI	Class I	Active
Hausted	4600-PS-SH	FDA UDI	Class I	Active
Hausted	4600-FS-DW-ST	FDA UDI	Class I	Active
Lumex	FR601UH454	FDA UDI	Class I	Active
Hausted	4600-AA-WH	FDA UDI	Class I	Active
Intensa	748CB-PU	FDA UDI	Class I	Active
Lumex	FR597P9207	FDA UDI	Class I	Active
Intensa	IN587W409PA	FDA UDI	Class I	Active
Lumex	14025	FDA UDI	Class II	Active
Lumex	FR597G6725	FDA UDI	Class I	Active
Intensa	IN587WWH	FDA UDI	Class I	Active
Intensa	IN566GNAPA	FDA UDI	Class I	Active
Lumex	565DG427	FDA UDI	Class I	Active
Intensa	IN566DGH1311PA	FDA UDI	Class I	Active
Lumex	FR566DGHO6727	FDA UDI	Class I	Active
Intensa	460-FL-T3	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.