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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 27 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	LS900-42	FDA UDI	Class II	Active
Intensa	IN577RG1318PA	FDA UDI	Class I	Active
Intensa	IN587WHNAPA	FDA UDI	Class I	Active
Hausted	6200DA-ST	FDA UDI	Class I	Active
Intensa	420-DW-PU	FDA UDI	Class I	Active
LabTron	240	FDA UDI	Class II	Active
Lumex	FR587WD8516PA	FDA UDI	Class I	Active
Lumex	FR597G1305	FDA UDI	Class I	Active
Intensa	IN577RGH1315PA	FDA UDI	Class I	Active
Lumex	FR577RGH9214	FDA UDI	Class I	Active
Lumex	LF1031	FDA UDI	Class I	Active
Intensa	IN566GBT	FDA UDI	Class I	Active
Hausted	4600-AA-PS-PU	FDA UDI	Class I	Active
Intensa	IN587WH6717	FDA UDI	Class I	Active
Intensa	460-FL-TL	FDA UDI	Class I	Active
Lumex	FR566DGH1318	FDA UDI	Class I	Active
Intensa	IN597G9208	FDA UDI	Class I	Active
Lumex	FR577RGH1323PA	FDA UDI	Class I	Active
Intensa	IN566G6724PA	FDA UDI	Class I	Active
Lumex	FR566DGH1315	FDA UDI	Class I	Active
Intensa	420-DW-DB	FDA UDI	Class I	Active
Intensa	IN587W6705	FDA UDI	Class I	Active
Intensa	IN601PHSH	FDA UDI	Class I	Active
Lumex	FR577RGH9214PA	FDA UDI	Class I	Active
Intensa	610-DO	FDA UDI	Class I	Active
Labtron	500GY	FDA UDI	Class I	Active
Intensa	460-AA-PS-WG	FDA UDI	Class I	Active
Intensa	460-FL-WG	FDA UDI	Class I	Active
Everest & Jennings	907630C3A	FDA UDI	Class I	Active
Intensa	IN577RGHDB	FDA UDI	Class I	Active
Intensa	744B-T1	FDA UDI	Class I	Active
Intensa	744CB-T2-SBCSW	FDA UDI	Class I	Active
Lumex	FR601UH9208	FDA UDI	Class I	Active
Intensa	IN566DG8604	FDA UDI	Class I	Active
Intensa	7408-CB-BT	FDA UDI	Class I	Active
Intensa	IN577RGH1311PA	FDA UDI	Class I	Active
Intensa	620-DA-AQ	FDA UDI	Class I	Active
Intensa	744B-T10	FDA UDI	Class I	Active
Intensa	IN577RGWH	FDA UDI	Class I	Active
Intensa	460-FS-DW-DB	FDA UDI	Class I	Active
Hausted	4600-PS-TE	FDA UDI	Class I	Active
Everest & Jennings	3F012120	FDA UDI	Class I	Active
Everest & Jennings	90763550	FDA UDI	Class I	Active
Basic American Medical Products	ZZ9817448	FDA UDI	Class II	Active
Intensa	IN577RGHSTPA	FDA UDI	Class I	Active
Intensa	IN566DGH6724	FDA UDI	Class I	Active
Labtron	513LB	FDA UDI	Class I	Active
Intensa	7408-CB-PM	FDA UDI	Class I	Active
Everest & Jennings	90763156	FDA UDI	Class I	Active
Intensa	IN577RG8516PA	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.