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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 65 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	7-1630E	FDA UDI	Class I	Active
Hausted	4600-FL-AQ	FDA UDI	Class I	Active
Intensa	IN566GMO	FDA UDI	Class I	Active
Intensa	420-DW-TL	FDA UDI	Class I	Active
Intensa	IN577RGHTE	FDA UDI	Class I	Active
Hausted	4200-WG	FDA UDI	Class I	Active
Everest & Jennings	90763SE16	FDA UDI	Class I	Active
Labtron	LAB-7100	FDA UDI	Class I	Active
Intensa	IN577RG9208	FDA UDI	Class I	Active
Lumex	FR601PH8602	FDA UDI	Class I	Active
Grafco	3953 3/4	FDA UDI	Class I	Active
Intensa	IN566DGPLPA	FDA UDI	Class I	Active
Grafco	8376	FDA UDI	Class II	Active
Intensa	IN587WDHBUPA	FDA UDI	Class I	Active
Lumex	FR577RGH6724	FDA UDI	Class I	Active
Hausted	4200-WH	FDA UDI	Class I	Active
Intensa	IN597P409	FDA UDI	Class I	Active
Intensa	460-AA-PM	FDA UDI	Class I	Active
Intensa	IN566DGH8615PA	FDA UDI	Class I	Active
Lumiscope	100-001NCHI	FDA UDI	Class II	Active
Lumex	FR565TG863	FDA UDI	Class I	Active
Lumex	FR587WH8604PA	FDA UDI	Class I	Active
Hausted	4600-AA-PS-AQ	FDA UDI	Class I	Active
Lumex	FR577RGH8604PA	FDA UDI	Class I	Active
Everest & Jennings	9P190E01J	FDA UDI	Class I	Active
Everest & Jennings	EJ78-CDCA	FDA UDI	Class I	Active
Lumex	FR597P9722	FDA UDI	Class I	Active
Intensa	IN597G9207	FDA UDI	Class I	Active
Lumex	FR577RGH1325	FDA UDI	Class I	Active
Lumex	FR587WH9212	FDA UDI	Class I	Active
Intensa	460-FS-DW-WG	FDA UDI	Class I	Active
Intensa	IN587WDH1305	FDA UDI	Class I	Active
Lumex	FR587WDH8584PA	FDA UDI	Class I	Active
Lumex	GF113-C-LC	FDA UDI	Class I	Active
Intensa	IN577RGPU	FDA UDI	Class I	Active
Lumex	FR601PH9207	FDA UDI	Class I	Active
Intensa	IN566DGH8516PA	FDA UDI	Class I	Active
Intensa	IN587WHNA	FDA UDI	Class I	Active
Intensa	460-AA-GR	FDA UDI	Class I	Active
Lumex	FR587WDH9201PA	FDA UDI	Class I	Active
Gendron	7155P1199	FDA UDI	Class I	Active
Labtron	300DLX-Y	FDA UDI	Class I	Active
Intensa	IN587WWWPA	FDA UDI	Class I	Active
Intensa	620-BL	FDA UDI	Class I	Active
Lumex	FR587WDH1311	FDA UDI	Class I	Active
Intensa	460-FS-PS-WH	FDA UDI	Class I	Active
Intensa	IN587WHVIPA	FDA UDI	Class I	Active
Intensa	IN566GPL	FDA UDI	Class I	Active
M368in566g1325pa1	IN566G1325PA	FDA UDI	Class I	Active
Lumex	FR601ULHO427	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.