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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 18 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	4600-WW	FDA UDI	Class I	Active
Intensa	IN587WHWG	FDA UDI	Class I	Active
Intensa	460-FL-T4	FDA UDI	Class I	Active
Intensa	460-FL-WH	FDA UDI	Class I	Active
Intensa	IN566DG1305PA	FDA UDI	Class I	Active
Intensa	IN566GH8615	FDA UDI	Class I	Active
Intensa	IN566DG8615	FDA UDI	Class I	Active
Lumex	FR587WH8602	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRPINKA	FDA UDI	Class I	Active
Intensa	IN587W432	FDA UDI	Class I	Active
Everest & Jennings	8100186	FDA UDI	Class I	Active
Intensa	IN577RGH9201	FDA UDI	Class I	Active
Intensa	460-FS-AA-DO	FDA UDI	Class I	Active
Lumex	FR566DG6717PA	FDA UDI	Class I	Active
Lumex	FR601UL427	FDA UDI	Class I	Active
Lumiscope	2214.CE	FDA UDI	Class II	Active
Intensa	620-VI	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-T1	FDA UDI	Class I	Active
Intensa	420-EO-WW	FDA UDI	Class I	Active
Lumex	FR577RG1304	FDA UDI	Class I	Active
Health Team	HT1859	FDA UDI	Class II	Active
Grafco	UNNA3	FDA UDI	Class I	Active
Intensa	420-EO-COM	FDA UDI	Class I	Active
Lumex	US0468-PKG	FDA UDI	Class II	Active
Intensa	IN587WMO	FDA UDI	Class I	Active
Everest & Jennings	907630A3A	FDA UDI	Class I	Active
Intensa	460-DW-GR	FDA UDI	Class I	Active
Lumex	7910A-1	FDA UDI	Class I	Active
Hausted	4200-EO-NO	FDA UDI	Class I	Active
John Bunn	JB0112-061	FDA UDI	Class II	Active
Basic American Medical Products	MAP49174	FDA UDI	Class II	Active
Intensa	460-FS-DW-GR	FDA UDI	Class I	Active
Hausted	4600-AA-PS-PL	FDA UDI	Class I	Active
Lumex	LCM4880	FDA UDI	Class II	Active
Intensa	IN587WD8584	FDA UDI	Class I	Active
Intensa	744-BL-SBCSW	FDA UDI	Class I	Active
Grafco	3396	FDA UDI	Class I	Active
Lumex	LF2020-DSLSA2	FDA UDI	Class I	Active
Hausted	4200-DW-PU	FDA UDI	Class I	Active
Intensa	620-BT	FDA UDI	Class I	Active
Intensa	IN587WMOPA	FDA UDI	Class I	Active
Intensa	620-OG	FDA UDI	Class I	Active
Lumex	FR565G427	FDA UDI	Class I	Active
Intensa	IN577RGHNA	FDA UDI	Class I	Active
Hausted	4200-DW-DO	FDA UDI	Class I	Active
Intensa	460-DW-TE	FDA UDI	Class I	Active
Intensa	IN597P1319	FDA UDI	Class I	Active
Hausted	4600-FS-PS-VI	FDA UDI	Class I	Active
Hausted	4600-AA-FS-BL	FDA UDI	Class I	Active
John Bunn	GF64095	FDA UDI	Class II	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.