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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 33 of 91

Device	Model / Reference	Registries	Class	Status
Grafco	3256	FDA UDI	Class I	Active
Intensa	IN577RGHAQPA	FDA UDI	Class I	Active
LUMEX Essentials	81218	FDA UDI	Class I	Active
Lumex	FR566DGH427PA	FDA UDI	Class I	Active
Hausted	4600-SH	FDA UDI	Class I	Active
Lumex	FR587WDH9208	FDA UDI	Class I	Active
Intensa	IN587WNO	FDA UDI	Class I	Active
Hausted	6200-AL	FDA UDI	Class I	Active
Intensa	620-DA-T7	FDA UDI	Class I	Active
Lumex	FR566DGH1319PA	FDA UDI	Class I	Active
Intensa	620-T5	FDA UDI	Class I	Active
Hausted	6200-WH	FDA UDI	Class I	Active
Grafco	1197F#2	FDA UDI	Class I	Active
Everest & Jennings	3H021100	FDA UDI	Class I	Active
Hausted	4600-AA-FS-AL	FDA UDI	Class I	Active
Intensa	748-WG	FDA UDI	Class I	Active
Intensa	620-DA-WH	FDA UDI	Class I	Active
Intensa	IN566DGH401	FDA UDI	Class I	Active
Intensa	IN566GH427	FDA UDI	Class I	Active
Hausted	4600-AA-PS-WG	FDA UDI	Class I	Active
Intensa	460-FS-TE	FDA UDI	Class I	Active
Intensa	IN587WHPLPA	FDA UDI	Class I	Active
Hausted	4600-FS-AL	FDA UDI	Class I	Active
Intensa	IN587WD454	FDA UDI	Class I	Active
Intensa	IN566GHAQPA	FDA UDI	Class I	Active
Grafco	2713	FDA UDI	Class I	Active
Intensa	IN587WDH401	FDA UDI	Class I	Active
Lumex	FR566DGHO427	FDA UDI	Class I	Active
Hausted	4600-FS-MO	FDA UDI	Class I	Active
Lumex	FR566DG8604PA	FDA UDI	Class I	Active
Hausted	4600-TE	FDA UDI	Class I	Active
Intensa	460-FS-AA-SH	FDA UDI	Class I	Active
Grafco	410E	FDA UDI	Class II	Active
Intensa	460-AL	FDA UDI	Class I	Active
Intensa	IN601UVI	FDA UDI	Class I	Active
Intensa	460-FS-T8	FDA UDI	Class I	Active
Intensa	744CB-MO	FDA UDI	Class I	Active
Lumex	FR601UH9214	FDA UDI	Class I	Active
Intensa	460-FS-PS-T5	FDA UDI	Class I	Active
Lumex	FR566GH1323	FDA UDI	Class I	Active
Intensa	IN566GHPLPA	FDA UDI	Class I	Active
Intensa	744B-BL-SW	FDA UDI	Class I	Active
Intensa	IN587WHTLPA	FDA UDI	Class I	Active
Intensa	7408-B-PM	FDA UDI	Class I	Active
Lumex	FR601UH9201	FDA UDI	Class I	Active
Intensa	IN587WDH9212	FDA UDI	Class I	Active
Everest & Jennings	EJ78-SGA	FDA UDI	Class I	Active
Lumex	FR587WDH9214PA	FDA UDI	Class I	Active
Lumex	FR597G6724	FDA UDI	Class I	Active
Intensa	IN566G1305PA	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.