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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 16 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	6200DA-DB	FDA UDI	Class I	Active
Intensa	460-PM	FDA UDI	Class I	Active
Hausted	4600-AA-DW-DB	FDA UDI	Class I	Active
John Bunn	JB02007	FDA UDI	Class II	Active
Intensa	748B-T2	FDA UDI	Class I	Active
Everest & Jennings	3E050120	FDA UDI	Class I	Active
M368in566g4271	IN566G427	FDA UDI	Class I	Active
Hausted	4600-NA	FDA UDI	Class I	Active
Intensa	460-FS-DW-WH	FDA UDI	Class I	Active
Hausted	6200-PL	FDA UDI	Class I	Active
Everest & Jennings	3F020130	FDA UDI	Class I	Active
Lumiscope	6700	FDA UDI	Class II	Active
Hausted	4200-EO-AR	FDA UDI	Class I	Active
Intensa	IN587WD-T3	FDA UDI	Class I	Active
Intensa	IN587W8615	FDA UDI	Class I	Active
Lumex	FR587WDH9205	FDA UDI	Class I	Active
Lumex	FR566DG8561PA	FDA UDI	Class I	Active
Intensa	460-FS-AA-BU	FDA UDI	Class I	Active
Intensa	IN566DG6705PA	FDA UDI	Class I	Active
Intensa	IN587WD427	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRSILVER	FDA UDI	Class I	Active
John Bunn	JB0112-164	FDA UDI	Class II	Active
Intensa	IN577RGH9208	FDA UDI	Class I	Active
Hausted	4600-FS-TE	FDA UDI	Class I	Active
Intensa	IN597G8615	FDA UDI	Class I	Active
Intensa	460-FL-PM	FDA UDI	Class I	Active
Labtron	400	FDA UDI	Class I	Active
Intensa	744B-BU	FDA UDI	Class I	Active
Intensa	IN566G9208PA	FDA UDI	Class I	Active
Intensa	748B-PM	FDA UDI	Class I	Active
Lumex	FR566G9208PA	FDA UDI	Class I	Active
Lumex	FR587W8615PA	FDA UDI	Class I	Active
Intensa	IN587WD8567	FDA UDI	Class I	Active
Everest & Jennings	9B045035J	FDA UDI	Class I	Active
Labtron	507P	FDA UDI	Class I	Active
Intensa	460-FS-DW-T5	FDA UDI	Class I	Active
Intensa	IN587W8602	FDA UDI	Class I	Active
Intensa	IN587WDH401PA	FDA UDI	Class I	Active
Grafco	2757	FDA UDI	Class I	Active
Intensa	460-FS-DW-COM	FDA UDI	Class I	Active
Intensa	748-T3	FDA UDI	Class I	Active
Hausted	4600-AA-TE	FDA UDI	Class I	Active
Intensa	IN566DGH401PA	FDA UDI	Class I	Active
Lumex	LS400	FDA UDI	Class II	Active
Intensa	IN587WD1311	FDA UDI	Class I	Active
Grafco	2609	FDA UDI	Class I	Active
Intensa	460-AA-PS-TL	FDA UDI	Class I	Active
Intensa	IN577RGWGPA	FDA UDI	Class I	Active
Lumex	574G427	FDA UDI	Class I	Active
Intensa	IN566G-T6	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.