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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 63 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN587WHWH	FDA UDI	Class I	Active
Lumex	FR566GH9208PA	FDA UDI	Class I	Active
Intensa	744CB-T4	FDA UDI	Class I	Active
Intensa	744CB-NA	FDA UDI	Class I	Active
Lumex	FR566G8567PA	FDA UDI	Class I	Active
Hausted	4600-AL	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-WG	FDA UDI	Class I	Active
Intensa	7408-CB-ST	FDA UDI	Class I	Active
Intensa	IN587WH8602PA	FDA UDI	Class I	Active
John Bunn	JB02020	FDA UDI	Class II	Active
Intensa	IN577RG6727PA	FDA UDI	Class I	Active
Lumex	FR566DGH401PA	FDA UDI	Class I	Active
Lumex	FR601UH409	FDA UDI	Class I	Active
Intensa	IN587WD9205PA	FDA UDI	Class I	Active
Grafco	UNNA-C3	FDA UDI	Class I	Active
Intensa	IN577RG9201	FDA UDI	Class I	Active
Hausted	4600-FS-DW-AL	FDA UDI	Class I	Active
Lumex	FR566GH9210	FDA UDI	Class I	Active
Basic American Medical Products	Z7F35	FDA UDI	Class II	Active
Intensa	460-PS-TE	FDA UDI	Class I	Active
Lumex	FR566GH432	FDA UDI	Class I	Active
Lumex	GF72004	FDA UDI	Class I	Active
Lumex	FR587W401PA	FDA UDI	Class I	Active
Intensa	7408-CB-SH	FDA UDI	Class I	Active
Lumex	MC000480	FDA UDI	Class I	Active
Intensa	460-FS-PS-AQ	FDA UDI	Class I	Active
Lumex	LS900P	FDA UDI	Class II	Active
Lumex	FR597P8602	FDA UDI	Class I	Active
Intensa	IN566GH1325	FDA UDI	Class I	Active
Intensa	460-PS-PL	FDA UDI	Class I	Active
Intensa	IN601PHTE	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-DO	FDA UDI	Class I	Active
Intensa	IN601UHDO	FDA UDI	Class I	Active
SIMMONS Clinical Care	760000SP	FDA UDI	Class II	Active
Intensa	IN566GH9207PA	FDA UDI	Class I	Active
Lumex	GF72002	FDA UDI	Class I	Active
Lumex	FR587W9205PA	FDA UDI	Class I	Active
Hausted	4600-AA-FS-GR	FDA UDI	Class I	Active
Basic American Medical Products	APS58174	FDA UDI	Class II	Active
Hausted	4600-WH	FDA UDI	Class I	Active
Lumex	AQ2000-2	FDA UDI	Class II	Active
Hausted	4600-AA-PS-MO	FDA UDI	Class I	Active
Grafco	4507-1	FDA UDI	Class II	Active
Lumex	GF8902	FDA UDI	Class I	Active
Intensa	IN566DGH8604	FDA UDI	Class I	Active
Labtron	400GY	FDA UDI	Class I	Active
Lumex	FM111	FDA UDI	Class II	Active
Lumex	LCM4280RB	FDA UDI	Class II	Active
Intensa	IN587WDH1315PA	FDA UDI	Class I	Active
Intensa	460-FS-T1	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.