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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 13 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	744CB-DB	FDA UDI	Class I	Active
Intensa	748-PU	FDA UDI	Class I	Active
Intensa	460-FS-PS-T6	FDA UDI	Class I	Active
Grafco	3856	FDA UDI	Class I	Active
Hausted	6200-GR	FDA UDI	Class I	Active
Everest & Jennings	8265206	FDA UDI	Class I	Active
Lumiscope	204-006	FDA UDI	Class I	Unknown
Intensa	IN601PNO	FDA UDI	Class I	Active
Intensa	IN577RGH1304PA	FDA UDI	Class I	Active
Everest & Jennings	9P835215J	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-BU	FDA UDI	Class I	Active
Hausted	4600-AA-DW-WH	FDA UDI	Class I	Active
Intensa	IN566DGH8602PA	FDA UDI	Class I	Active
Intensa	460-FS-PS-COM	FDA UDI	Class I	Active
Transfer Master	B407-F-C	FDA UDI	Class II	Active
Intensa	420-EO-AQ	FDA UDI	Class I	Active
Lumex	FR587WH1315PA	FDA UDI	Class I	Active
Lumex	FR577RG8602PA	FDA UDI	Class I	Active
Lumex	LS900-36	FDA UDI	Class II	Active
LabTron	200BK	FDA UDI	Class II	Active
Intensa	IN587WH454PA	FDA UDI	Class I	Active
Intensa	IN587W1319	FDA UDI	Class I	Active
Intensa	460-AA-DW-GR	FDA UDI	Class I	Active
Lumex	FR577RG6714PA	FDA UDI	Class I	Active
Everest & Jennings	90763041	FDA UDI	Class I	Active
Intensa	IN566DGH9212	FDA UDI	Class I	Active
Lumex	FR566DG9207PA	FDA UDI	Class I	Active
Intensa	IN597P1304	FDA UDI	Class I	Active
LabTron	240C	FDA UDI	Class II	Active
Intensa	IN577RGH1305PA	FDA UDI	Class I	Active
Intensa	IN587WDWH	FDA UDI	Class I	Active
Lumex	FR587WD8602PA	FDA UDI	Class I	Active
Intensa	460-AA-DW-T5	FDA UDI	Class I	Active
Intensa	460-AA-DW-DB	FDA UDI	Class I	Active
Intensa	IN597P401	FDA UDI	Class I	Active
Intensa	IN566GH8584PA	FDA UDI	Class I	Active
Basic American Medical Products	MAZ49174	FDA UDI	Class II	Active
Hausted	4600-AA-FS-SH	FDA UDI	Class I	Active
Intensa	IN597GWH	FDA UDI	Class I	Active
Basic American Medical Products	APS98174	FDA UDI	Class II	Active
Intensa	IN587WH6717PA	FDA UDI	Class I	Active
Everest & Jennings	3H020340	FDA UDI	Class I	Active
Grafco	2798	FDA UDI	Class I	Active
Intensa	748-BL	FDA UDI	Class I	Active
Intensa	IN587W6705PA	FDA UDI	Class I	Active
Intensa	420-BU	FDA UDI	Class I	Active
Intensa	IN577RG9210	FDA UDI	Class I	Active
Intensa	IN566G6717PA	FDA UDI	Class I	Active
Intensa	460-FS-AA-WW	FDA UDI	Class I	Active
Intensa	460-AA-WG	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.