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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 24 of 91

Device	Model / Reference	Registries	Class	Status
Everest & Jennings	90835175J	FDA UDI	Class I	Active
Intensa	IN566GHPUPA	FDA UDI	Class I	Active
Intensa	IN566DGWHPA	FDA UDI	Class I	Active
Intensa	IN601UHSH	FDA UDI	Class I	Active
Intensa	IN597GBT	FDA UDI	Class I	Active
Intensa	IN587WH1318	FDA UDI	Class I	Active
Lumex	FR565WG8504	FDA UDI	Class I	Active
Lumiscope	2210	FDA UDI	Class II	Active
Lumex	FR587WD6717PA	FDA UDI	Class I	Active
Intensa	460-AA-PS-TE	FDA UDI	Class I	Active
Intensa	748-AQ	FDA UDI	Class I	Active
Intensa	IN566GH9208	FDA UDI	Class I	Active
Everest & Jennings	90835204J	FDA UDI	Class I	Active
Intensa	460-FS-DW-NA	FDA UDI	Class I	Active
Health Team	HT1857	FDA UDI	Class II	Active
Intensa	IN587WD1318PA	FDA UDI	Class I	Active
Intensa	IN587WDHDO	FDA UDI	Class I	Active
Everest & Jennings	90763050	FDA UDI	Class I	Active
Intensa	420-EO-OG	FDA UDI	Class I	Active
Intensa	IN566GAL	FDA UDI	Class I	Active
Grafco	3261	FDA UDI	Class I	Active
Intensa	IN587WDH8584PA	FDA UDI	Class I	Active
Intensa	IN597G1319	FDA UDI	Class I	Active
Intensa	620-T1	FDA UDI	Class I	Active
Lumex	FR587WDH9207PA	FDA UDI	Class I	Active
Intensa	744CB-PM	FDA UDI	Class I	Active
Lumex	FR601UH8604	FDA UDI	Class I	Active
Intensa	460-AA-BT	FDA UDI	Class I	Active
Hausted	4600-AA-FS-BT	FDA UDI	Class I	Active
Intensa	460-FS-AA-TL	FDA UDI	Class I	Active
Lumex	FR601PH8584	FDA UDI	Class I	Active
Intensa	IN566GH9212PA	FDA UDI	Class I	Active
Intensa	IN587W9208PA	FDA UDI	Class I	Active
Everest & Jennings	EJ795-1	FDA UDI	Class I	Active
Lumex	FR601PH8615	FDA UDI	Class I	Active
Basic American Medical Products	ZZA9967406	FDA UDI	Class II	Active
Intensa	IN587WHPU	FDA UDI	Class I	Active
Intensa	IN566DG1325PA	FDA UDI	Class I	Active
Everest & Jennings	907632A1A	FDA UDI	Class I	Active
Intensa	744-GR	FDA UDI	Class I	Active
Intensa	610-T7	FDA UDI	Class I	Active
Intensa	460-FS-T3	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-WG	FDA UDI	Class I	Active
Hausted	4600-FS-PS-WG	FDA UDI	Class I	Active
Intensa	IN587WDH1323	FDA UDI	Class I	Active
Hausted	4600-AA-ST	FDA UDI	Class I	Active
Lumex	FR566G432PA	FDA UDI	Class I	Active
Hausted	6200-WG	FDA UDI	Class I	Active
Lumex	13630	FDA UDI	Class I	Active
Intensa	IN566DG6725PA	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.