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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 79 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR601PH1319	FDA UDI	Class I	Active
Intensa	IN597GMO	FDA UDI	Class I	Active
Hausted	4200-DW-BU	FDA UDI	Class I	Active
Hausted	6200DA-BT	FDA UDI	Class I	Active
Intensa	IN587WWG	FDA UDI	Class I	Active
Intensa	744-PL	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-T10	FDA UDI	Class I	Active
Intensa	460-PS-WW	FDA UDI	Class I	Active
Intensa	IN587WDH6705	FDA UDI	Class I	Active
Intensa	460-FS-DW-BU	FDA UDI	Class I	Active
Lumex	FR587WD1311PA	FDA UDI	Class I	Active
Intensa	IN566GHSHPA	FDA UDI	Class I	Active
Lumex	FR587WD409PA	FDA UDI	Class I	Active
Everest & Jennings	907632B3A	FDA UDI	Class I	Active
Hausted	4600-WG	FDA UDI	Class I	Active
Intensa	IN587WHAL	FDA UDI	Class I	Active
Hausted	4600-AA-PS-NO	FDA UDI	Class I	Active
Everest & Jennings	90763013A	FDA UDI	Class I	Active
Intensa	IN597PDO	FDA UDI	Class I	Active
Lumex	FR565WG8561	FDA UDI	Class I	Active
Hausted	4600-FS-VI	FDA UDI	Class I	Active
Lumex	FR587WD6725PA	FDA UDI	Class I	Active
Hausted	4600-FL-AR	FDA UDI	Class I	Active
Lumex	FR577RG454PA	FDA UDI	Class I	Active
Lumex	FR577RG427PA	FDA UDI	Class I	Active
Intensa	IN577RGH432PA	FDA UDI	Class I	Active
Everest & Jennings	90763060	FDA UDI	Class I	Active
Intensa	IN601UHPL	FDA UDI	Class I	Active
Lumex	FR587W1304PA	FDA UDI	Class I	Active
Intensa	420-EO-AL	FDA UDI	Class I	Active
Lumex	FR587W6717PA	FDA UDI	Class I	Active
Intensa	IN601UST	FDA UDI	Class I	Active
Intensa	744B-VI	FDA UDI	Class I	Active
Intensa	744CB-BL	FDA UDI	Class I	Active
Intensa	IN566GH1315PA	FDA UDI	Class I	Active
Grafco	4109	FDA UDI	Class I	Active
Lumex	FR577RG9210PA	FDA UDI	Class I	Active
Lumex	7103	FDA UDI	Class I	Active
Intensa	IN577RG6714PA	FDA UDI	Class I	Active
Lumex	FR601UH8567	FDA UDI	Class I	Active
Intensa	IN566DGHNOPA	FDA UDI	Class I	Active
Intensa	420-COM	FDA UDI	Class I	Active
Intensa	IN597G6714	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-PL	FDA UDI	Class I	Active
Intensa	IN566GVI	FDA UDI	Class I	Active
Intensa	IN577RGH8584PA	FDA UDI	Class I	Active
Intensa	IN587WH8604	FDA UDI	Class I	Active
Intensa	IN587WDHWHPA	FDA UDI	Class I	Active
Lumex	TP333	FDA UDI	Class I	Active
Lumex	FR566DGH9212	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.