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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 69 of 91

Device	Model / Reference	Registries	Class	Status
Everest & Jennings	EJ785-1	FDA UDI	Class I	Active
Lumex	FR565DG863	FDA UDI	Class I	Active
Lumex	7931RA	FDA UDI	Class I	Active
Grafco	1197	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRAQUA	FDA UDI	Class I	Active
Intensa	IN597G1318	FDA UDI	Class I	Active
Lumex	IN577RGPLPA	FDA UDI	Class I	Active
Intensa	IN566GH8584	FDA UDI	Class I	Active
Lumex	FR577RGH8567	FDA UDI	Class I	Active
Labtron	400P	FDA UDI	Class I	Active
Lumex	FR566DGH8561	FDA UDI	Class I	Unknown
Lumex	FR577RGH1311	FDA UDI	Class I	Active
Intensa	IN566DGHGRPA	FDA UDI	Class I	Active
Intensa	IN566GHWWPA	FDA UDI	Class I	Active
Intensa	420-DW-DO	FDA UDI	Class I	Active
Lumex	FR565G863	FDA UDI	Class I	Active
Lumex	FR577RGH8584	FDA UDI	Class I	Active
Intensa	IN601PHOG	FDA UDI	Class I	Active
Intensa	460-DW-VI	FDA UDI	Class I	Active
Hausted	4600-AA-PS-SH	FDA UDI	Class I	Active
Intensa	IN601UPL	FDA UDI	Class I	Active
Lumex	FR601UH9207	FDA UDI	Class I	Active
Gendron	PL700S	FDA UDI	Class II	Active
Hausted	4600-NO	FDA UDI	Class I	Active
Intensa	460-PS-AQ	FDA UDI	Class I	Active
Intensa	IN587WNOPA	FDA UDI	Class I	Active
Lumex	FR577RG1325PA	FDA UDI	Class I	Active
Intensa	IN566DGHWG	FDA UDI	Class I	Active
Intensa	IN566DGHDB	FDA UDI	Class I	Active
Intensa	IN566DGH9210	FDA UDI	Class I	Active
Intensa	460-AA-PS-GR	FDA UDI	Class I	Active
Intensa	460-AA-PU	FDA UDI	Class I	Active
Lumex	FR565WG9210	FDA UDI	Class I	Active
Intensa	420-T5	FDA UDI	Class I	Active
Hausted	4E7APRST	FDA UDI	Class II	Unknown
Intensa	7408-CB-TL	FDA UDI	Class I	Active
Everest & Jennings	8265208	FDA UDI	Class I	Active
Intensa	IN597GBL	FDA UDI	Class I	Active
Intensa	460-AA-PS-ST	FDA UDI	Class I	Active
Lumex	US5000	FDA UDI	Class II	Active
Lumex	FR587WDH1319PA	FDA UDI	Class I	Active
Everest & Jennings	EJ78-BACKRELA	FDA UDI	Class I	Active
Intensa	IN566G8567	FDA UDI	Class I	Active
Lumex	FR587WD9208PA	FDA UDI	Class I	Active
Hausted	4200-GR	FDA UDI	Class I	Active
Lumex	FR566GH1325	FDA UDI	Class I	Active
Intensa	IN577RG1323	FDA UDI	Class I	Active
Lumex	FR566G454PA	FDA UDI	Class I	Active
Everest & Jennings	9P835209J	FDA UDI	Class I	Active
Intensa	IN577RG8604PA	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.