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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 67 of 91

Device	Model / Reference	Registries	Class	Status
Transfer Master	B310-5-T	FDA UDI	Class II	Active
Intensa	IN601UBT	FDA UDI	Class I	Active
Grafco	1196	FDA UDI	Class I	Active
Lumex	FR587WDH427PA	FDA UDI	Class I	Active
Lumex	FR601PLH427	FDA UDI	Class I	Active
Hausted	4600-DW-TL	FDA UDI	Class I	Active
Grafco	2710	FDA UDI	Class I	Active
Lumex	FR601PH432	FDA UDI	Class I	Active
Hausted	4200-AR	FDA UDI	Class I	Active
Lumex	FR587WDH6717PA	FDA UDI	Class I	Active
Intensa	460-AA-DW-MO	FDA UDI	Class I	Active
Intensa	IN566DGH6717	FDA UDI	Class I	Active
Intensa	IN577RGPMPA	FDA UDI	Class I	Active
Hausted	4600-AA-DW-TE	FDA UDI	Class I	Active
Labtron	602N-OR	FDA UDI	Class I	Active
Hausted	4600-DW-AQ	FDA UDI	Class I	Active
Intensa	748-TE	FDA UDI	Class I	Active
Intensa	744-T3	FDA UDI	Class I	Active
Intensa	460-AA-PS-AL	FDA UDI	Class I	Active
Grafco	UNNA4	FDA UDI	Class I	Active
Intensa	IN587WH6714PA	FDA UDI	Class I	Active
Hausted	4600-AA-WW	FDA UDI	Class I	Active
Intensa	IN566DGPL	FDA UDI	Class I	Active
Intensa	IN587WDHBLPA	FDA UDI	Class I	Active
Lumex	FR566DGH409PA	FDA UDI	Class I	Active
Gendron	G2618-750	FDA UDI	Class I	Active
Basic American Medical Products	APS981741	FDA UDI	Class II	Active
Lumex	FR597P454	FDA UDI	Class I	Active
Intensa	IN566DG409	FDA UDI	Class I	Active
Hausted	4600-FS-NO	FDA UDI	Class I	Active
Intensa	744B-OG	FDA UDI	Class I	Active
Grafco	1799-10P	FDA UDI	N	Active
Intensa	IN566G9210PA	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-NO	FDA UDI	Class I	Active
Intensa	IN587WDHGRPA	FDA UDI	Class I	Active
Everest & Jennings	9B232870J	FDA UDI	Class I	Active
Intensa	IN587WDHSTPA	FDA UDI	Class I	Active
Lumex	FR597PH9210	FDA UDI	Class I	Active
Lumex	FR577RGH8615	FDA UDI	Class I	Active
Intensa	460-FS-PS-GR	FDA UDI	Class I	Active
Hausted	4200-EO-BT	FDA UDI	Class I	Active
Everest & Jennings	3K010230	FDA UDI	Class I	Active
Lumex	FR597PH427	FDA UDI	Class I	Active
Intensa	IN597PSH	FDA UDI	Class I	Active
Intensa	IN577RGH427PA	FDA UDI	Class I	Active
Intensa	IN566GWWPA	FDA UDI	Class I	Active
Lumex	FR587WD8584PA	FDA UDI	Class I	Active
Intensa	7408-CB-NO	FDA UDI	Class I	Active
Intensa	620-PL	FDA UDI	Class I	Active
Lumex	FR587WH6724PA	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.