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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 2 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN601UHNO	FDA UDI	Class I	Active
Grafco	2670	FDA UDI	Class I	Active
Intensa	IN577RGH9201PA	FDA UDI	Class I	Active
Intensa	IN566GHNA	FDA UDI	Class I	Active
Intensa	IN601P-COM	FDA UDI	Class I	Active
Lumex	FR577RG401PA	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRREDA	FDA UDI	Class I	Active
Intensa	744-OG	FDA UDI	Class I	Active
Intensa	744CB-WW	FDA UDI	Class I	Active
Intensa	IN587WDH9205	FDA UDI	Class I	Active
Hausted	4600-FL-BL	FDA UDI	Class I	Active
Intensa	IN577RGH6705	FDA UDI	Class I	Active
Intensa	IN601UWW	FDA UDI	Class I	Active
Everest & Jennings	90763052A	FDA UDI	Class I	Active
Lumex	FR566G9207PA	FDA UDI	Class I	Active
Intensa	IN587WH1323PA	FDA UDI	Class I	Active
Everest & Jennings	23040120	FDA UDI	Class I	Active
Intensa	748-SH	FDA UDI	Class I	Active
Lumex	FR566DGH6724	FDA UDI	Class I	Active
Lumex	FR565WG6717	FDA UDI	Class I	Active
Lumex	FR587WDH1305PA	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-AL	FDA UDI	Class I	Active
Hausted	4600-AA-FS-WW	FDA UDI	Class I	Active
Intensa	748-BT	FDA UDI	Class I	Active
Lumex	FR587W9210PA	FDA UDI	Class I	Active
Lumex	FR587WDH9214	FDA UDI	Class I	Active
Lumex	FR587W1311PA	FDA UDI	Class I	Active
Intensa	IN587WD9201	FDA UDI	Class I	Active
Lumex	FR597P8584	FDA UDI	Class I	Active
Everest & Jennings	3H020320	FDA UDI	Class I	Active
Intensa	IN566DGH1319	FDA UDI	Class I	Active
Hausted	EPC250ST	FDA UDI	Class I	Unknown
Intensa	IN566GVIPA	FDA UDI	Class I	Active
Intensa	IN587WH9212	FDA UDI	Class I	Active
Everest & Jennings	90763730	FDA UDI	Class I	Active
Intensa	744-TL-SBCSW	FDA UDI	Class I	Active
Intensa	IN587WDH6717	FDA UDI	Class I	Active
Intensa	420-NA	FDA UDI	Class I	Active
Intensa	460-DW-SH	FDA UDI	Class I	Active
Grafco	1799-50P	FDA UDI	N	Active
Intensa	IN601PHBU	FDA UDI	Class I	Active
Intensa	620-T4	FDA UDI	Class I	Active
Intensa	IN566DGCAP08	FDA UDI	Class I	Active
Lumex	FR566DG6705PA	FDA UDI	Class I	Active
Lumex	FR587WH8584PA	FDA UDI	Class I	Active
Lumex	FR587WDH401PA	FDA UDI	Class I	Active
Everest & Jennings	3H020140	FDA UDI	Class I	Active
Intensa	IN587WDH9201PA	FDA UDI	Class I	Active
Intensa	460-FS-PS-PL	FDA UDI	Class I	Active
Hausted	4200-VI	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.