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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 25 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	610-PU	FDA UDI	Class I	Active
Intensa	IN587WD1311PA	FDA UDI	Class I	Active
Everest & Jennings	EJ79-CST-FSA	FDA UDI	Class I	Active
Lumex	FR587W1319PA	FDA UDI	Class I	Active
Lumex	LF2090	FDA UDI	Class I	Active
Lumex	FR566DGH1315PA	FDA UDI	Class I	Active
Intensa	IN587WTEPA	FDA UDI	Class I	Active
Intensa	IN601UHWG	FDA UDI	Class I	Active
Lumex	FR587WH1325PA	FDA UDI	Class I	Active
Intensa	748-T7	FDA UDI	Class I	Active
Basic American Medical Products	APS581742	FDA UDI	Class II	Active
Hausted	6200-MO	FDA UDI	Class I	Active
Intensa	IN587W6714	FDA UDI	Class I	Active
Intensa	744CB-DO	FDA UDI	Class I	Active
Intensa	IN566DG8602PA	FDA UDI	Class I	Active
Hausted	4600-AA-FS-VI	FDA UDI	Class I	Active
Intensa	IN587WH9207	FDA UDI	Class I	Active
Intensa	IN587WBL	FDA UDI	Class I	Active
Hausted	4600-FL-MO	FDA UDI	Class I	Active
Intensa	IN587WH6727PA	FDA UDI	Class I	Active
Intensa	IN601PHVI	FDA UDI	Class I	Active
Intensa	748B-DO	FDA UDI	Class I	Active
Intensa	IN566DGHNO	FDA UDI	Class I	Active
Everest & Jennings	90835115J	FDA UDI	Class I	Active
Intensa	460-FS-NO	FDA UDI	Class I	Active
Intensa	IN577RGDBPA	FDA UDI	Class I	Active
Intensa	620-SH	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-GR	FDA UDI	Class I	Active
Lumex	FR566DGH1323	FDA UDI	Class I	Active
Hausted	6200-OG	FDA UDI	Class I	Active
Everest & Jennings	3H021120	FDA UDI	Class I	Active
Intensa	420-MO	FDA UDI	Class I	Active
Hausted	4600-FL-SH	FDA UDI	Class I	Active
Everest & Jennings	8920188	FDA UDI	Class I	Active
Intensa	IN587WD9201PA	FDA UDI	Class I	Active
Intensa	460-FL-T1	FDA UDI	Class I	Active
Grafco	2698	FDA UDI	Class I	Active
Intensa	7408-CB-MO	FDA UDI	Class I	Active
Intensa	460-AA-COM	FDA UDI	Class I	Active
Intensa	IN587WDHOG	FDA UDI	Class I	Active
Intensa	IN587WDHDB	FDA UDI	Class I	Active
Lumiscope	1133	FDA UDI	Class II	Active
Lumex	FR587WH9205PA	FDA UDI	Class I	Active
Intensa	IN577RGHWH	FDA UDI	Class I	Active
Intensa	IN587WHWGPA	FDA UDI	Class I	Active
Lumex	FR566G9201PA	FDA UDI	Class I	Active
Lumex	FR577RG1318PA	FDA UDI	Class I	Active
Lumex	FR566GH401	FDA UDI	Class I	Active
Intensa	IN566DGMO	FDA UDI	Class I	Active
Intensa	460-AA-BU	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.