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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 32 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	460-AA-DW-SH	FDA UDI	Class I	Active
Intensa	IN597PBU	FDA UDI	Class I	Active
Intensa	460-FS-AA-COM	FDA UDI	Class I	Active
Lumex	FR566DG9201PA	FDA UDI	Class I	Active
Lumex	FR597GH427	FDA UDI	Class I	Active
Everest & Jennings	8930166	FDA UDI	Class I	Active
Intensa	620-DA-TE	FDA UDI	Class I	Active
Lumex	FR566GH1304PA	FDA UDI	Class I	Active
Intensa	IN597G8567	FDA UDI	Class I	Active
Intensa	IN587WH1311	FDA UDI	Class I	Active
Intensa	IN577RG8584	FDA UDI	Class I	Active
Everest & Jennings	8920166	FDA UDI	Class I	Active
Intensa	460-AA-DW-PU	FDA UDI	Class I	Active
Lumex	FR566DGH6705PA	FDA UDI	Class I	Active
Intensa	460-FS-AL	FDA UDI	Class I	Active
Intensa	IN566DG9201	FDA UDI	Class I	Active
Intensa	IN566G9201PA	FDA UDI	Class I	Active
Hausted	4600-PS-MO	FDA UDI	Class I	Active
Lumex	FR566G6705PA	FDA UDI	Class I	Active
Intensa	460-FS-AA-T3	FDA UDI	Class I	Active
Intensa	7408-CB-AR	FDA UDI	Class I	Active
Hausted	4600-DW-PL	FDA UDI	Class I	Active
Everest & Jennings	90H35061J	FDA UDI	Class I	Active
Everest & Jennings	90763006A	FDA UDI	Class I	Active
Intensa	748CB-PM	FDA UDI	Class I	Active
Lumex	FR601UH401	FDA UDI	Class I	Active
Intensa	IN566DGVI	FDA UDI	Class I	Active
Intensa	IN587WPMPA	FDA UDI	Class I	Active
Intensa	460-FS-PS-DO	FDA UDI	Class I	Active
Hausted	6200-NO	FDA UDI	Class I	Active
Lumex	FR566DGH6727	FDA UDI	Class I	Active
Intensa	IN587WH6725PA	FDA UDI	Class I	Active
Intensa	IN577RGHWHPA	FDA UDI	Class I	Active
Everest & Jennings	907632A2A	FDA UDI	Class I	Active
Hausted	4200-DB	FDA UDI	Class I	Active
Lumex	DSHC70002	FDA UDI	Class I	Active
Intensa	420-DW-AQ	FDA UDI	Class I	Active
Everest & Jennings	8940186	FDA UDI	Class I	Active
Grafco	3397	FDA UDI	Class I	Active
Intensa	IN587WDPM	FDA UDI	Class I	Active
Lumex	US6000	FDA UDI	Class II	Active
Lumex	FR565WG8567	FDA UDI	Class I	Active
Intensa	460-FS-AA-AR	FDA UDI	Class I	Active
Lumex	FR577RG9212PA	FDA UDI	Class I	Active
Transfer Master	B407-Q84	FDA UDI	Class II	Active
Intensa	IN577RGSH	FDA UDI	Class I	Active
Grafco	3399-1	FDA UDI	Class I	Active
Intensa	IN597G9212	FDA UDI	Class I	Active
Intensa	744-SH-SW	FDA UDI	Class I	Active
Intensa	IN566GH6727PA	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.