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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 10 of 91

Device	Model / Reference	Registries	Class	Status
Transfer Master	B314-F	FDA UDI	Class II	Active
Labtron	300DLX	FDA UDI	Class I	Active
Intensa	420-OG	FDA UDI	Class I	Active
Lumex	FR577RGH1311PA	FDA UDI	Class I	Active
Hausted	4200-PL	FDA UDI	Class I	Active
Intensa	744CB-BL-SW	FDA UDI	Class I	Active
Intensa	IN566GH9205PA	FDA UDI	Class I	Active
Intensa	IN597P6725	FDA UDI	Class I	Active
Grafco	2624	FDA UDI	Class I	Active
Lumex	7915A-1	FDA UDI	Class I	Active
Hausted	4600-FL-TE	FDA UDI	Class I	Active
Intensa	460-FS-DW-BT	FDA UDI	Class I	Active
Intensa	IN587WAQPA	FDA UDI	Class I	Active
John Bunn	3255-6	FDA UDI	Class II	Active
Everest & Jennings	3J010330	FDA UDI	Class I	Active
Intensa	460-FS-PS-PM	FDA UDI	Class I	Active
Intensa	IN566G409	FDA UDI	Class I	Active
Grafco	3786-12#5	FDA UDI	Class I	Active
Lumex	FR577RGH9210PA	FDA UDI	Class I	Active
Intensa	IN566GH8604PA	FDA UDI	Class I	Active
Lumex	821817	FDA UDI	Class I	Active
Lumex	FR566G1304PA	FDA UDI	Class I	Active
Intensa	IN566G6705	FDA UDI	Class I	Active
Intensa	744B-NO	FDA UDI	Class I	Active
Intensa	IN577RGST	FDA UDI	Class I	Active
Intensa	IN587WDWG	FDA UDI	Class I	Active
Intensa	IN566DGHVIPA	FDA UDI	Class I	Active
Lumex	FR566DGH8604PA	FDA UDI	Class I	Active
Intensa	744B-AQ	FDA UDI	Class I	Active
Hausted	4600-FS-DW-BU	FDA UDI	Class I	Active
Intensa	IN566GHMO	FDA UDI	Class I	Active
Lumex	FR601PH9201	FDA UDI	Class I	Active
Intensa	IN566DGHTL	FDA UDI	Class I	Active
Intensa	IN577RG8516	FDA UDI	Class I	Active
Intensa	IN601UTE	FDA UDI	Class I	Active
Hausted	6200-TL	FDA UDI	Class I	Active
Lumex	FR587WH6714PA	FDA UDI	Class I	Active
Lumex	FR597G8567	FDA UDI	Class I	Active
Lumex	FR577RGH1315	FDA UDI	Class I	Active
Intensa	460-FL-MO	FDA UDI	Class I	Active
Lumex	FR601PH409	FDA UDI	Class I	Active
Intensa	IN587WHDOPA	FDA UDI	Class I	Active
Hausted	4600-PS-BT	FDA UDI	Class I	Active
Intensa	744-SH	FDA UDI	Class I	Active
Grafco	GF-TX5	FDA UDI	Class II	Active
Intensa	744B-ST	FDA UDI	Class I	Active
Intensa	IN587WDBLPA	FDA UDI	Class I	Active
Intensa	IN601UOG	FDA UDI	Class I	Active
Everest & Jennings	90763150	FDA UDI	Class I	Active
Intensa	IN587WD8567PA	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.