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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 37 of 91

Device	Model / Reference	Registries	Class	Status
Grafco	9677R	FDA UDI	Class I	Active
Intensa	IN597PWG	FDA UDI	Class I	Active
Lumex	FR565WG8626	FDA UDI	Class I	Active
Intensa	IN601U-T5	FDA UDI	Class I	Active
Intensa	420-BT	FDA UDI	Class I	Active
Intensa	IN566DGWGPA	FDA UDI	Class I	Active
Lumex	FR577RG1319PA	FDA UDI	Class I	Active
Lumex	FR577RG8584PA	FDA UDI	Class I	Active
Lumex	FR587WH1325	FDA UDI	Class I	Active
Intensa	460-FS-PS-WW	FDA UDI	Class I	Active
Transfer Master	B311-FSL	FDA UDI	Class II	Active
Intensa	460-AA-T2	FDA UDI	Class I	Active
Lumex	FR577RG9208PA	FDA UDI	Class I	Active
Intensa	IN577RGHWWPA	FDA UDI	Class I	Active
Intensa	IN577RGH6705PA	FDA UDI	Class I	Active
Intensa	IN587WDHWWPA	FDA UDI	Class I	Active
Lumex	GF7014-1	FDA UDI	Class I	Active
Intensa	IN601PAR	FDA UDI	Class I	Active
Hausted	4600-FS-DW-SH	FDA UDI	Class I	Active
Grafco	2860	FDA UDI	Class I	Active
Everest & Jennings	23040110	FDA UDI	Class I	Active
Intensa	IN577RGAQPA	FDA UDI	Class I	Active
Lumex	FR566DGH8611	FDA UDI	Class I	Active
Grafco	2861	FDA UDI	Class I	Active
Transfer Master	MLB-F/Q-HL	FDA UDI	Class II	Active
Intensa	620-NA	FDA UDI	Class I	Active
Lumex	FR587WH8602PA	FDA UDI	Class I	Active
Lumex	FR597P9208	FDA UDI	Class I	Active
Intensa	IN566GH9201PA	FDA UDI	Class I	Active
Intensa	IN577RGOGPA	FDA UDI	Class I	Active
Intensa	IN587WDHST	FDA UDI	Class I	Active
Intensa	IN566G1318	FDA UDI	Class I	Active
Intensa	744CB-PL	FDA UDI	Class I	Active
Grafco	2769	FDA UDI	Class I	Active
Lumex	FR587WDH8611	FDA UDI	Class I	Active
Intensa	IN587W1325	FDA UDI	Class I	Active
Intensa	748CB-WW	FDA UDI	Class I	Active
Everest & Jennings	8940240	FDA UDI	Class I	Active
Intensa	748B-GR	FDA UDI	Class I	Active
Intensa	IN587WDNAPA	FDA UDI	Class I	Active
Lumex	FR565WG8602	FDA UDI	Class I	Active
Intensa	610L-SH	FDA UDI	Class I	Active
Intensa	IN577RGH1304	FDA UDI	Class I	Active
Lumex	FR566G9524	FDA UDI	Class I	Active
Hausted	4600-DW-ST	FDA UDI	Class I	Active
Intensa	744CB-T7	FDA UDI	Class I	Active
Intensa	748CB-T10	FDA UDI	Class I	Active
Intensa	460-FS-DW-AL	FDA UDI	Class I	Active
Grafco	2607	FDA UDI	Class I	Active
Intensa	460-FL-T10	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.