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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 88 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN587W6717PA	FDA UDI	Class I	Active
Intensa	IN587WDHVI	FDA UDI	Class I	Active
Intensa	744B-AL	FDA UDI	Class I	Active
Intensa	IN566G6705PA	FDA UDI	Class I	Active
Intensa	IN566DGHDO	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-NA	FDA UDI	Class I	Active
Intensa	IN566DGDO	FDA UDI	Class I	Active
Intensa	IN587WH1319PA	FDA UDI	Class I	Active
Intensa	748CB-T2-SCBSW	FDA UDI	Class I	Active
Intensa	IN566DGH1305	FDA UDI	Class I	Active
Intensa	460-PS-T2	FDA UDI	Class I	Active
Intensa	IN587WDVIPA	FDA UDI	Class I	Active
Intensa	460-DW-T1	FDA UDI	Class I	Active
Intensa	IN587W401	FDA UDI	Class I	Active
Grafco	1822	FDA UDI	Class I	Active
Grafco	2733	FDA UDI	Class I	Active
Gfafco	1698M	FDA UDI	Class I	Active
Intensa	748B-COM	FDA UDI	Class I	Active
Gendron	7155P183	FDA UDI	Class I	Active
Intensa	420-AL	FDA UDI	Class I	Active
Everest & Jennings	90835071J	FDA UDI	Class I	Active
Basic American Medical Products	ZZ78674	FDA UDI	Class II	Active
Everest & Jennings	3K010130	FDA UDI	Class I	Active
Intensa	IN597PNO	FDA UDI	Class I	Active
Intensa	460-AA-DW-WH	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-GR	FDA UDI	Class I	Active
Intensa	460-FS-DW-T2	FDA UDI	Class I	Active
Grafco	3399-2	FDA UDI	Class I	Active
Intensa	7408-B-DO	FDA UDI	Class I	Active
Intensa	7408-B-BL	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-T8	FDA UDI	Class I	Active
Basic American Medical Products	ZG58674	FDA UDI	Class II	Active
Intensa	748-T6	FDA UDI	Class I	Active
John Bunn	1398-1#5	FDA UDI	Class II	Active
Intensa	IN566DGAL	FDA UDI	Class I	Active
John Bunn	1395-1#5	FDA UDI	Class II	Active
Lumex	FR601P8615	EUDAMEDFDA UDI	Class I	Active
Hausted	5B800ST	EUDAMEDFDA UDI	Class I	Active
Hausted	462EMCST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U9210	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P1325	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P9210	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U454	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG6725	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9517	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG1323	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W1311	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD8516	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG9214	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD8615	EUDAMEDFDA 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.