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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 78 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR587W1315PA	FDA UDI	Class I	Active
Lumex	FR566DGH1311PA	FDA UDI	Class I	Active
Intensa	IN566DG8604PA	FDA UDI	Class I	Active
Intensa	IN587WD1319	FDA UDI	Class I	Active
Intensa	IN601UBL	FDA UDI	Class I	Active
Lumex	GF4405863	FDA UDI	Class I	Active
Intensa	460-DW-COM	FDA UDI	Class I	Active
Intensa	620-DA-T10	FDA UDI	Class I	Active
Everest & Jennings	3K010350	FDA UDI	Class I	Active
Hausted	4600-PS-GR	FDA UDI	Class I	Active
Intensa	IN587WPLPA	FDA UDI	Class I	Active
Lumex	FR577RGH6717	FDA UDI	Class I	Active
Intensa	IN587WPM	FDA UDI	Class I	Active
Lumex	FMC116	FDA UDI	Class II	Active
Intensa	IN566GHAL	FDA UDI	Class I	Active
Lumex	FR566GH8615	FDA UDI	Class I	Active
Everest & Jennings	EJ78-ARMSA	FDA UDI	Class I	Active
Lumex	DSLSA3	FDA UDI	Class I	Active
John Bunn	JB0112-062	FDA UDI	Class II	Active
Intensa	460-AA-DW-ST	FDA UDI	Class I	Active
Lumex	FR566G8615PA	FDA UDI	Class I	Active
Lumex	FR597G9607	FDA UDI	Class I	Active
Intensa	IN566G1325	FDA UDI	Class I	Active
Transfer Master	B306-Q	FDA UDI	Class II	Active
Intensa	460-AA-DW-T4	FDA UDI	Class I	Active
Everest & Jennings	90763043A	FDA UDI	Class I	Active
Lumex	FR601U6725	FDA UDI	Class I	Active
Intensa	IN587WDHWH	FDA UDI	Class I	Active
Intensa	420-T9	FDA UDI	Class I	Active
Lumiscope	100-019LA	FDA UDI	Class II	Active
Basic American Medical Products	ZAG99174	FDA UDI	Class II	Active
Everest & Jennings	3H021220	FDA UDI	Class I	Active
Everest & Jennings	EJ79-HANDLESA	FDA UDI	Class I	Active
Lumex	FR587WDHO427	FDA UDI	Class I	Active
Intensa	IN577RGHOGPA	FDA UDI	Class I	Active
Lumex	FR566DGH6717PA	FDA UDI	Class I	Active
Intensa	420-EO/DW SHELL	FDA UDI	Class I	Active
Intensa	460-AA-DW-T7	FDA UDI	Class I	Active
Intensa	460-FS-DW-T7	FDA UDI	Class I	Active
Intensa	748CB-T8	FDA UDI	Class I	Active
Hausted	6200DA-SH	FDA UDI	Class I	Active
Lumex	FR587WH9207	FDA UDI	Class I	Active
Intensa	460-AA-DW-TE	FDA UDI	Class I	Active
Intensa	420-DW-MO	FDA UDI	Class I	Active
John Bunn	JB0112-110	FDA UDI	Class II	Active
Everest & Jennings	90763015A	FDA UDI	Class I	Active
Intensa	IN577RGHPUPA	FDA UDI	Class I	Active
Lumex	FR565WG8615	FDA UDI	Class I	Active
Intensa	460-FS-PS-T8	FDA UDI	Class I	Active
Lumex	FR587WDH1323PA	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.