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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 23 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN601PPM	FDA UDI	Class I	Active
Intensa	IN577RG8602	FDA UDI	Class I	Active
Lumex	FR587WH8615	FDA UDI	Class I	Active
Lumex	FR565WG8808	FDA UDI	Class I	Active
Lumex	8220188	FDA UDI	Class I	Active
Lumex	FR597G9606	FDA UDI	Class I	Active
Intensa	IN587WDHPL	FDA UDI	Class I	Active
Lumex	FR566GH8604PA	FDA UDI	Class I	Active
LabTron	223B	FDA UDI	Class II	Active
Intensa	IN577RGNO	FDA UDI	Class I	Active
Intensa	IN597PTE	FDA UDI	Class I	Active
Lumex	FR577RGH9524PA	FDA UDI	Class I	Active
Lumex	FR565WG1323	FDA UDI	Class I	Active
Intensa	IN587WDPL	FDA UDI	Class I	Active
Lumiscope	100-001CHI	FDA UDI	Class II	Active
Intensa	420-EO-BL	FDA UDI	Class I	Active
Intensa	IN587WDHGR	FDA UDI	Class I	Active
Grafco	9677	FDA UDI	Class I	Active
Everest & Jennings	90763051A	FDA UDI	Class I	Active
Intensa	IN587WDH427PA	FDA UDI	Class I	Active
Intensa	IN587W1323	FDA UDI	Class I	Active
Intensa	IN566DGH1311	FDA UDI	Class I	Active
Everest & Jennings	907630C1A	FDA UDI	Class I	Active
Lumex	FR587WH8516PA	FDA UDI	Class I	Active
Intensa	748B-T6	FDA UDI	Class I	Active
Intensa	748CB-MO	FDA UDI	Class I	Active
Lumex	FR566DGH9208PA	FDA UDI	Class I	Active
Intensa	460-AA-PS-DW-OG	FDA UDI	Class I	Active
Intensa	IN597PAR	FDA UDI	Class I	Active
Intensa	748-T10	FDA UDI	Class I	Active
Intensa	420-DW-WW	FDA UDI	Class I	Active
Grafco	2608	FDA UDI	Class I	Active
Lumex	FR566DGH8624	FDA UDI	Class I	Unknown
Lumex	LS900MAT36	FDA UDI	Class II	Active
Intensa	460-FS-DW-PM	FDA UDI	Class I	Active
Intensa	IN587WDHWGPA	FDA UDI	Class I	Active
Grafco	3814	FDA UDI	Class II	Active
Intensa	460-AA-PS-NO	FDA UDI	Class I	Active
Grafco	2653	FDA UDI	Class I	Active
Everest & Jennings	8565186	FDA UDI	Class I	Active
Everest & Jennings	24040100	FDA UDI	Class I	Active
Intensa	IN601UHNA	FDA UDI	Class I	Active
Lumex	FR566DGH8801	FDA UDI	Class I	Unknown
Intensa	IN597PST	FDA UDI	Class I	Active
Intensa	IN577RGHTL	FDA UDI	Class I	Active
Lumex	7016A	FDA UDI	Class I	Active
Lumex	FR587WD9517PA	FDA UDI	Class I	Active
Intensa	460-AA-PS-VI	FDA UDI	Class I	Active
Gendron	TRC28750-FB	FDA UDI	Class I	Active
Lumex	FR597G401	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.