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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 68 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	4600-PS-DB	FDA UDI	Class I	Active
Lumex	FR597G454	FDA UDI	Class I	Active
Grafco	1698CM	FDA UDI	Class I	Active
Intensa	748-T4	FDA UDI	Class I	Active
Lumex	FR601PH9205	FDA UDI	Class I	Active
Intensa	IN566G-T2	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-WW	FDA UDI	Class I	Active
Intensa	IN566G8516PA	FDA UDI	Class I	Active
John Bunn	GF33239	FDA UDI	Class I	Active
Intensa	IN587WDSHPA	FDA UDI	Class I	Active
Basic American Medical Products	AR981541	FDA UDI	Class II	Active
Lumex	FR566DGH1304PA	FDA UDI	Class I	Active
Intensa	IN587WHALPA	FDA UDI	Class I	Active
John Bunn	1398-1#4	FDA UDI	Class II	Active
Intensa	748CB-T5	FDA UDI	Class I	Active
Lumex	FR577RG9207PA	FDA UDI	Class I	Active
Intensa	IN587W9205	FDA UDI	Class I	Active
Everest & Jennings	90763132	FDA UDI	Class I	Active
Grafco	2692	FDA UDI	Class I	Active
Hausted	6200-BU	FDA UDI	Class I	Active
Intensa	7408-B-PL	FDA UDI	Class I	Active
Lumex	AQ2000	FDA UDI	Class II	Active
Intensa	IN566DG6727PA	FDA UDI	Class I	Active
Intensa	7408-CB-GR	FDA UDI	Class I	Active
Intensa	IN587WDHDBPA	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-T2	FDA UDI	Class I	Active
Intensa	IN587WH1323	FDA UDI	Class I	Active
Hausted	6200DA-BL	FDA UDI	Class I	Active
Lumex	FR566DG1304	FDA UDI	Class I	Active
Intensa	IN566DGHPU	FDA UDI	Class I	Active
Intensa	IN577RG9207	FDA UDI	Class I	Active
Lumex	US0458	FDA UDI	Class II	Active
Hausted	4600-FS-DW-DO	FDA UDI	Class I	Active
Transfer Master	B407-F	FDA UDI	Class II	Active
Intensa	748B-PU	FDA UDI	Class I	Active
Intensa	IN566GHNAPA	FDA UDI	Class I	Active
Hausted	4600-FS-BL	FDA UDI	Class I	Active
Everest & Jennings	90763231A	FDA UDI	Class I	Active
Intensa	IN566G9212PA	FDA UDI	Class I	Active
Lumex	FR601PHO427	FDA UDI	Class I	Active
Lumex	FR565WG9208	FDA UDI	Class I	Active
Lumex	FR597GHO427	FDA UDI	Class I	Active
Intensa	IN577RGVIPA	FDA UDI	Class I	Active
Intensa	IN577RGTEPA	FDA UDI	Class I	Active
Intensa	IN587WDORB60	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-T3	FDA UDI	Class I	Active
Lumex	FR577RGH8567PA	FDA UDI	Class I	Active
Intensa	IN566G9214PA	FDA UDI	Class I	Active
Intensa	460-AA-DW-NA	FDA UDI	Class I	Active
Intensa	IN587WDH6717PA	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.