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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 75 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN587W6727PA	FDA UDI	Class I	Active
Grafco	3399-3	FDA UDI	Class I	Active
Intensa	IN587W432PA	FDA UDI	Class I	Active
Intensa	460-FS-GR	FDA UDI	Class I	Active
Intensa	460-FS-PS-T7	FDA UDI	Class I	Active
Intensa	7408-CB-BU	FDA UDI	Class I	Active
Intensa	IN566GH1318PA	FDA UDI	Class I	Active
Intensa	460-AA-DW-WG	FDA UDI	Class I	Active
Lumex	FR597G9205	FDA UDI	Class I	Active
Intensa	IN587W8567	FDA UDI	Class I	Active
Everest & Jennings	3G010430	FDA UDI	Class I	Active
Intensa	IN566DGH9205	FDA UDI	Class I	Active
LabTron	202S-X	FDA UDI	Class II	Active
Lumex	FR587WH1319PA	FDA UDI	Class I	Active
Intensa	IN587WDBL	FDA UDI	Class I	Active
Intensa	IN587WD6727	FDA UDI	Class I	Active
Lumex	FR565WG9715	FDA UDI	Class I	Active
Gendron	GS3648	FDA UDI	Class II	Active
Intensa	IN566DGH1325PA	FDA UDI	Class I	Active
Basic American Medical Products	M6AF42	FDA UDI	Class II	Active
Lumex	FR566G1315PA	FDA UDI	Class I	Active
Intensa	460-FS-PS-PU	FDA UDI	Class I	Active
Intensa	IN587WPL	FDA UDI	Class I	Active
Hausted	4200-EO-TE	FDA UDI	Class I	Active
Intensa	620-DA-GR	FDA UDI	Class I	Active
Intensa	IN587WDSTPA	FDA UDI	Class I	Active
Intensa	IN601PHNO	FDA UDI	Class I	Active
Lumex	8220186	FDA UDI	Class I	Active
Intensa	IN601PTE	FDA UDI	Class I	Active
Intensa	IN587WDH1318PA	FDA UDI	Class I	Active
Intensa	620-DA-T3	FDA UDI	Class I	Active
Hausted	4600-AA-DW-WW	FDA UDI	Class I	Active
Intensa	IN597P1305	FDA UDI	Class I	Active
Intensa	IN577RGH9212PA	FDA UDI	Class I	Active
Lumex	FR566G427PA	FDA UDI	Class I	Active
Intensa	620-DA-PM	FDA UDI	Class I	Active
Intensa	748B-TL	FDA UDI	Class I	Active
Intensa	IN587WDHBT	FDA UDI	Class I	Active
Intensa	460-PS-WH	FDA UDI	Class I	Active
Intensa	748-T2	FDA UDI	Class I	Active
Intensa	IN566DGARPA	FDA UDI	Class I	Active
Intensa	IN597PGR	FDA UDI	Class I	Active
Intensa	IN597G401	FDA UDI	Class I	Active
Intensa	IN587WDH6725PA	FDA UDI	Class I	Active
Grafco	3254	FDA UDI	Class I	Active
Hausted	6200DA-WG	FDA UDI	Class I	Active
Lumex	FR566GH1311	FDA UDI	Class I	Active
Lumex	FR601UH9205	FDA UDI	Class I	Active
Intensa	460-FS-DW-WW	FDA UDI	Class I	Active
Lumex	FR566DG432PA	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.