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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 61 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN566GH8602PA	FDA UDI	Class I	Active
Lumex	FR601PH8567	FDA UDI	Class I	Active
Lumiscope	100-001	FDA UDI	Class II	Active
Intensa	IN587WNAPA	FDA UDI	Class I	Active
Everest & Jennings	90763056	FDA UDI	Class I	Active
Intensa	IN577RGHWG	FDA UDI	Class I	Active
Intensa	IN566DGHWWPA	FDA UDI	Class I	Active
Lumex	FR566DG409PA	FDA UDI	Class I	Active
Intensa	IN597P454	FDA UDI	Class I	Active
Lumex	UPH862	FDA UDI	Class I	Active
Everest & Jennings	90H35218J	FDA UDI	Class I	Active
Intensa	460-AA-DW-BU	FDA UDI	Class I	Active
Grafco	1312-2	FDA UDI	Class I	Active
Intensa	IN566DG8584PA	FDA UDI	Class I	Active
Intensa	IN577RG1311	FDA UDI	Class I	Active
Intensa	IN577RG6717PA	FDA UDI	Class I	Active
Lumex	FR587WDH6727PA	FDA UDI	Class I	Active
Intensa	460-FS-AA-PL	FDA UDI	Class I	Active
Intensa	IN566G9207	FDA UDI	Class I	Active
Intensa	IN587W9201	FDA UDI	Class I	Active
Lumex	8565188CS	FDA UDI	Class I	Active
Intensa	IN566GH6724PA	FDA UDI	Class I	Active
Intensa	IN577RGHNOPA	FDA UDI	Class I	Active
Intensa	IN566GHBLPA	FDA UDI	Class I	Active
Intensa	IN566GH6705PA	FDA UDI	Class I	Active
Hausted	4600-VI	FDA UDI	Class I	Active
Intensa	460-FS-COM	FDA UDI	Class I	Active
Lumex	FR597P1319	FDA UDI	Class I	Active
Everest & Jennings	3G010520	FDA UDI	Class I	Active
Intensa	IN597P1318	FDA UDI	Class I	Active
Intensa	IN577RG9210PA	FDA UDI	Class I	Active
Lumex	FR601PH1323	FDA UDI	Class I	Active
Everest & Jennings	8565206	FDA UDI	Class I	Active
Intensa	460-FS-DB	FDA UDI	Class I	Active
Intensa	620-PM	FDA UDI	Class I	Active
Everest & Jennings	9P835330J	FDA UDI	Class I	Active
Lumex	FR601ULH427	FDA UDI	Class I	Active
Hausted	4600-AA-PS-DO	FDA UDI	Class I	Active
Everest & Jennings	90763070A	FDA UDI	Class I	Active
Intensa	IN587WDH8602	FDA UDI	Class I	Active
Intensa	744-DO	FDA UDI	Class I	Active
Intensa	IN566GH432PA	FDA UDI	Class I	Active
Intensa	IN597GNA	FDA UDI	Class I	Active
Lumex	FR566DG9210PA	FDA UDI	Class I	Active
Intensa	IN587W6724	FDA UDI	Class I	Active
Intensa	IN597P1325	FDA UDI	Class I	Active
Grafco	1697-2	FDA UDI	Class I	Active
Everest & Jennings	90763208A	FDA UDI	Class I	Active
Intensa	IN587WDHBL	FDA UDI	Class I	Active
Grafco	3953 1/2	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.