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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 4 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	4600-AA-PS-OG	FDA UDI	Class I	Active
Hausted	4600-AA-DW-BL	FDA UDI	Class I	Active
Lumex	FR566GH9207	FDA UDI	Class I	Active
Labtron	500BK	FDA UDI	Class I	Active
Intensa	420-EO SHELL	FDA UDI	Class I	Active
Intensa	IN587W8567PA	FDA UDI	Class I	Active
Intensa	IN577RG9205	FDA UDI	Class I	Active
Everest & Jennings	3G010530	FDA UDI	Class I	Active
Lumex	FR597G9207	FDA UDI	Class I	Active
Everest & Jennings	EJ78-BACK17A	FDA UDI	Class I	Active
Intensa	460-FS-PS-BT	FDA UDI	Class I	Active
Intensa	IN587WDH427	FDA UDI	Class I	Active
Grafco	3258	FDA UDI	Class I	Active
Lumex	FR565WG8809	FDA UDI	Class I	Active
Lumex	DSC260	FDA UDI	Class I	Active
Intensa	IN566GH1319	FDA UDI	Class I	Active
Basic American Medical Products	MZ49174	FDA UDI	Class II	Active
Intensa	IN566GHPMPA	FDA UDI	Class I	Active
Everest & Jennings	907632C2A	FDA UDI	Class I	Active
Grafco	1304-1	FDA UDI	Class I	Active
Intensa	IN566GNA	FDA UDI	Class I	Active
Hausted	4600-FS-DW-VI	FDA UDI	Class I	Active
Intensa	460-FS-DW-T3	FDA UDI	Class I	Active
Intensa	460-DW-WH	FDA UDI	Class I	Active
Intensa	IN577RGH432	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-WH	FDA UDI	Class I	Active
Intensa	IN597P9210	FDA UDI	Class I	Active
Everest & Jennings	EJ76-BELTA	FDA UDI	Class I	Active
LabTron	202N	FDA UDI	Class II	Active
Intensa	IN597P6705	FDA UDI	Class I	Active
Intensa	748B-TE	FDA UDI	Class I	Active
Hausted	4200-EO-DB	FDA UDI	Class I	Active
Hausted	6200-AQ	FDA UDI	Class I	Active
Intensa	IN587WD454PA	FDA UDI	Class I	Active
Intensa	IN566DG454	FDA UDI	Class I	Active
Intensa	IN566GH6725PA	FDA UDI	Class I	Active
Hausted	4200-EO-PM	FDA UDI	Class I	Active
Lumex	FR577RGH427	FDA UDI	Class I	Active
Intensa	460-AA-PS-T1	FDA UDI	Class I	Active
Lumex	FR566DGH9208	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-AR	FDA UDI	Class I	Active
Hausted	4600-FS-PS-AR	FDA UDI	Class I	Active
Intensa	460-FS-NA	FDA UDI	Class I	Active
Lumex	GF4405857	FDA UDI	Class I	Active
Intensa	IN566GHVIPA	FDA UDI	Class I	Active
Hausted	4600-FS-DW-OG	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-PU	FDA UDI	Class I	Active
Intensa	IN566GHWGPA	FDA UDI	Class I	Active
Lumex	FR597P9205	FDA UDI	Class I	Active
Labtron	602R	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.