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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 55 of 91

Device	Model / Reference	Registries	Class	Status
LUMEX Essentials	81220	FDA UDI	Class I	Active
Hausted	6200-VI	FDA UDI	Class I	Active
Intensa	IN566GH454	FDA UDI	Class I	Active
Gendron	GT5XL	FDA UDI	Class II	Active
Intensa	IN577RGH6725PA	FDA UDI	Class I	Active
Intensa	IN566GHTE	FDA UDI	Class I	Active
Grafco	GF-3	FDA UDI	Class II	Active
Intensa	IN601UHAR	FDA UDI	Class I	Active
Labtron	602BL	FDA UDI	Class I	Active
Lumex	FR587WH9201	FDA UDI	Class I	Active
Intensa	IN577RGH1305	FDA UDI	Class I	Active
Lumex	STS500	FDA UDI	Class II	Active
Intensa	460-T5	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRBLACKA	FDA UDI	Class I	Active
Lumex	F112	FDA UDI	Class II	Active
Intensa	IN587WD6717	FDA UDI	Class I	Active
Intensa	744CB-T8	FDA UDI	Class I	Active
Intensa	IN597GST	FDA UDI	Class I	Active
Lumex	DSLSA2	FDA UDI	Class I	Active
Gendron	GS4748SD	FDA UDI	Class II	Active
Intensa	744CB-T5	FDA UDI	Class I	Active
Intensa	IN566GHDB	FDA UDI	Class I	Active
Lumex	FR565WG9722	FDA UDI	Class I	Active
Intensa	IN601UTL	FDA UDI	Class I	Active
Intensa	460-AA-PS-T7	FDA UDI	Class I	Active
Intensa	744-PM	FDA UDI	Class I	Active
Intensa	460-FS-PS-ST	FDA UDI	Class I	Active
Everest & Jennings	90763170	FDA UDI	Class I	Unknown
Intensa	IN566DGH6725	FDA UDI	Class I	Active
Intensa	420-EO-PL	FDA UDI	Class I	Active
Lumex	FR565DG427	FDA UDI	Class I	Active
Lumex	FR597G6717	FDA UDI	Class I	Active
Lumex	FR566G8584PA	FDA UDI	Class I	Active
Lumex	FR566GH9208	FDA UDI	Class I	Active
Intensa	IN577RGH8584	FDA UDI	Class I	Active
Lumex	FR597G6727	FDA UDI	Class I	Active
Intensa	IN587WAR	FDA UDI	Class I	Active
Everest & Jennings	3H020200	FDA UDI	Class I	Active
Hausted	4600-AA-FS-NO	FDA UDI	Class I	Active
Intensa	IN566DGTL	FDA UDI	Class I	Active
Intensa	IN587WDALPA	FDA UDI	Class I	Active
Lumex	FR597P8516	FDA UDI	Class I	Active
Intensa	748-PL	FDA UDI	Class I	Active
Intensa	420-GR	FDA UDI	Class I	Active
Intensa	460-BT	FDA UDI	Class I	Active
Everest & Jennings	3E050100	FDA UDI	Class I	Active
Intensa	460-FS-DW-T10	FDA UDI	Class I	Active
Lumex	FR587WH9208PA	FDA UDI	Class I	Active
Lumex	FR566DGH8584	FDA UDI	Class I	Active
Grafco	3395-1	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.