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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 72 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN566G6724	FDA UDI	Class I	Active
Labtron	300DLX-BL	FDA UDI	Class I	Active
Hausted	4600-FS-DW-AQ	FDA UDI	Class I	Active
Grafco	2721	FDA UDI	Class I	Active
Intensa	IN597PNA	FDA UDI	Class I	Active
Intensa	IN566DGBU	FDA UDI	Class I	Active
Everest & Jennings	8265186	FDA UDI	Class I	Active
Intensa	IN577RGHGR	FDA UDI	Class I	Active
LabTron	202I	FDA UDI	Class II	Active
LabTron	175GY	FDA UDI	Class II	Active
Intensa	460-PS-DB	FDA UDI	Class I	Active
Intensa	460-FS-BU	FDA UDI	Class I	Active
Hausted	4600-DW-AR	FDA UDI	Class I	Active
Intensa	IN587WT5	FDA UDI	Class I	Active
Intensa	IN587WDWW	FDA UDI	Class I	Active
Everest & Jennings	90763020A	FDA UDI	Class I	Active
Lumex	FR577RGH454	FDA UDI	Class I	Active
Intensa	620-PU	FDA UDI	Class I	Active
Intensa	IN587WDH6724	FDA UDI	Class I	Active
Intensa	IN577RGMOPA	FDA UDI	Class I	Active
Hausted	4600-FS-DW-MO	FDA UDI	Class I	Active
Lumex	FR601UH6725	FDA UDI	Class I	Active
Lumex	FR587WH9201PA	FDA UDI	Class I	Active
Hausted	4600-FS-PS-BL	FDA UDI	Class I	Active
Intensa	IN601PWG	FDA UDI	Class I	Active
Intensa	IN597GBU	FDA UDI	Class I	Active
Lumex	FR577RG8567PA	FDA UDI	Class I	Active
Everest & Jennings	907630B3A	FDA UDI	Class I	Active
Hausted	4600-AA-NA	FDA UDI	Class I	Active
Intensa	IN587WHDB	FDA UDI	Class I	Active
Hausted	4600-FS-PL	FDA UDI	Class I	Active
Everest & Jennings	90761415	FDA UDI	Class I	Active
Labtron	602BK	FDA UDI	Class I	Active
Labtron	507	FDA UDI	Class I	Active
Lumex	FR587W9751	FDA UDI	Class I	Active
Intensa	620-DA-NA	FDA UDI	Class I	Active
Everest & Jennings	5PX10820	FDA UDI	Class I	Active
Intensa	IN577RGHMO	FDA UDI	Class I	Active
Hausted	4600-FS-PS-DB	FDA UDI	Class I	Active
Lumex	DM81R	FDA UDI	Class I	Active
Intensa	IN587WD9212	FDA UDI	Class I	Active
Intensa	IN577RGWHPA	FDA UDI	Class I	Active
Intensa	748-NO	FDA UDI	Class I	Active
Lumiscope	100-040HG	FDA UDI	Class II	Active
Gendron	PL1000S	FDA UDI	Class II	Active
Intensa	IN566DGHMOPA	FDA UDI	Class I	Active
Intensa	IN566DG1304	FDA UDI	Class I	Active
Intensa	IN566GH8615PA	FDA UDI	Class I	Active
Transfer Master	B314-T	FDA UDI	Class II	Active
Intensa	IN601UBU	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.