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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 15 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	4600-FS-AA-PS-TL	FDA UDI	Class I	Active
Lumex	FR577RGH1318PA	FDA UDI	Class I	Active
Hausted	4600-FS-AQ	FDA UDI	Class I	Active
Intensa	IN566DG9210PA	FDA UDI	Class I	Active
LabTron	200GY	FDA UDI	Class II	Active
Lumex	5597R-54-1	FDA UDI	Class I	Active
Basic American Medical Products	Z9ASW	FDA UDI	Class II	Active
LabTron	175	FDA UDI	Class II	Active
Intensa	IN566GH9212	FDA UDI	Class I	Active
Labtron	602SF-GEL	FDA UDI	Class I	Active
Intensa	IN587WHTL	FDA UDI	Class I	Active
Intensa	IN577RGHPM	FDA UDI	Class I	Active
Lumex	TP332	FDA UDI	Class I	Active
Lumex	FR566DGH454	FDA UDI	Class I	Active
SIMMONS Clinical Care	765000S	FDA UDI	Class II	Active
Intensa	748-DB-SW	FDA UDI	Class I	Active
Lumex	FR565WG432	FDA UDI	Class I	Active
Intensa	620-DA-BL	FDA UDI	Class I	Active
John Bunn	1398-1#8	FDA UDI	Class II	Active
Intensa	IN587WH432PA	FDA UDI	Class I	Active
Hausted	4600-FS-SH	FDA UDI	Class I	Active
Everest & Jennings	3G010550	FDA UDI	Class I	Active
Everest & Jennings	3E050350	FDA UDI	Class I	Active
Intensa	420-EO-BT	FDA UDI	Class I	Active
Grafco	2200	FDA UDI	Class II	Active
Lumex	FR577RGH1304PA	FDA UDI	Class I	Active
Intensa	IN587W6714PA	FDA UDI	Class I	Active
Intensa	IN577RGSTPA	FDA UDI	Class I	Active
Everest & Jennings	90763062A	FDA UDI	Class I	Active
Hausted	4600-AA-PS-NA	FDA UDI	Class I	Active
Hausted	4200-DW-NO	FDA UDI	Class I	Active
SIMMONS Clinical Care	760000S	FDA UDI	Class II	Active
Lumex	FR566G409PA	FDA UDI	Class I	Active
Hausted	4600-FS-DW-TE	FDA UDI	Class I	Active
Grafco	1372-3	FDA UDI	Class I	Active
Intensa	IN587WDHTL	FDA UDI	Class I	Active
Health Team	1858CASE	FDA UDI	Class II	Active
Lumex	FR566GHO427PA	FDA UDI	Class I	Active
Intensa	IN577RG1318	FDA UDI	Class I	Active
Everest & Jennings	EJT500	FDA UDI	Class I	Active
Intensa	IN601UDB	FDA UDI	Class I	Active
Intensa	IN577RGAR	FDA UDI	Class I	Active
Lumex	FR577RG1304PA	FDA UDI	Class I	Active
Lumex	FR577RG1305PA	FDA UDI	Class I	Active
Intensa	IN587WHSH	FDA UDI	Class I	Active
Hausted	6200DA-WH	FDA UDI	Class I	Active
Lumex	FR565WG1319	FDA UDI	Class I	Active
Basic American Medical Products	Z9AF35	FDA UDI	Class II	Active
Intensa	460-FS-PM	FDA UDI	Class I	Active
Hausted	4600-AA-DW-VI	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.