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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 11 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN566DG427PA	FDA UDI	Class I	Active
Intensa	IN597P6717	FDA UDI	Class I	Active
Intensa	IN587WBNV25	FDA UDI	Class I	Active
Intensa	IN566DG432	FDA UDI	Class I	Active
Intensa	IN587WDHDOPA	FDA UDI	Class I	Active
Lumex	FR587WDH8615	FDA UDI	Class I	Active
Lumex	FR587WH432	FDA UDI	Class I	Active
Intensa	IN597P9208	FDA UDI	Class I	Active
Intensa	IN587WDBT	FDA UDI	Class I	Active
Intensa	IN587WDH454PA	FDA UDI	Class I	Active
Intensa	IN566G454PA	FDA UDI	Class I	Active
Hausted	4600-FS-BT	FDA UDI	Class I	Active
Hausted	4600-FL-BU	FDA UDI	Class I	Active
Intensa	IN587WDH1325PA	FDA UDI	Class I	Active
Intensa	IN597GSH	FDA UDI	Class I	Active
Intensa	IN566G6725	FDA UDI	Class I	Active
Intensa	IN587WDH409	FDA UDI	Class I	Active
Intensa	IN587WDH409PA	FDA UDI	Class I	Active
Lumex	FR587WH8584	FDA UDI	Class I	Active
Lumex	LS300	FDA UDI	Class II	Active
Lumex	GF7012-1	FDA UDI	Class I	Active
Grafco	4160	FDA UDI	Class I	Active
Grafco	1335	FDA UDI	Class I	Active
Intensa	460-DW-T4	FDA UDI	Class I	Active
Intensa	IN577RGGR	FDA UDI	Class I	Active
Intensa	IN587WD8602	FDA UDI	Class I	Active
Lumex	FR566DGH9214	FDA UDI	Class I	Active
Intensa	IN566GHTLPA	FDA UDI	Class I	Active
Lumex	FR587WHO427PA	FDA UDI	Class I	Active
Intensa	FR577RGH1319PA	FDA UDI	Class I	Active
Lumex	FR601UH6724	FDA UDI	Class I	Active
Intensa	IN566DG1315PA	FDA UDI	Class I	Active
Lumex	FR597G1304	FDA UDI	Class I	Active
Hausted	4600-FS-DW-WG	FDA UDI	Class I	Active
Grafco	3786B#0	FDA UDI	Class I	Active
Intensa	460-FS-DW-T4	FDA UDI	Class I	Active
Lumex	FR587WD6724PA	FDA UDI	Class I	Active
Hausted	4600-AA-DW-AQ	FDA UDI	Class I	Active
Intensa	744B-T9	FDA UDI	Class I	Active
Everest & Jennings	3F020230	FDA UDI	Class I	Active
Everest & Jennings	3E050110	FDA UDI	Class I	Active
Lumex	FR565WG8584	FDA UDI	Class I	Active
Intensa	IN587W9205PA	FDA UDI	Class I	Active
Lumex	FR601PH9210	FDA UDI	Class I	Active
Intensa	IN566GDBPA	FDA UDI	Class I	Active
Lumex	FR577RGH8602PA	FDA UDI	Class I	Active
Lumex	FR587W1319	FDA UDI	Class I	Active
Transfer Master	B407-F84	FDA UDI	Class II	Active
Intensa	744-WH	FDA UDI	Class I	Active
Intensa	748B-NO	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.