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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 84 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN566DGSH	FDA UDI	Class I	Active
Everest & Jennings	3H020120	FDA UDI	Class I	Active
Intensa	IN577RG6724PA	FDA UDI	Class I	Active
Intensa	IN597GTL	FDA UDI	Class I	Active
Intensa	IN566GAQ	FDA UDI	Class I	Active
LUMEX Essentials	81216	FDA UDI	Class I	Active
Intensa	IN587W9207PA	FDA UDI	Class I	Active
Labtron	400GR	FDA UDI	Class I	Active
Intensa	IN566G1319	FDA UDI	Class I	Active
Intensa	7408-CB-WH	FDA UDI	Class I	Active
Intensa	IN577RGHVIPA	FDA UDI	Class I	Active
Intensa	IN601PHAL	FDA UDI	Class I	Active
Intensa	IN587WDHPU	FDA UDI	Class I	Active
Intensa	460-OG	FDA UDI	Class I	Active
Intensa	IN597G432	FDA UDI	Class I	Active
Intensa	748-BU	FDA UDI	Class I	Active
Intensa	460-AA-DW-NO	FDA UDI	Class I	Active
Intensa	IN566G1311PA	FDA UDI	Class I	Active
Grafco	2646	FDA UDI	Class I	Active
Intensa	460-FS-PS-T2	FDA UDI	Class I	Active
Intensa	7408-B-WW	FDA UDI	Class I	Active
Intensa	620-DA-COM	FDA UDI	Class I	Active
Intensa	IN601UGR	FDA UDI	Class I	Active
Intensa	IN566DGHPUPA	FDA UDI	Class I	Active
Intensa	IN566DG8567	FDA UDI	Class I	Active
Intensa	IN566DG8615PA	FDA UDI	Class I	Active
Basic American Medical Products	APS7817400	FDA UDI	Class II	Active
Intensa	460-FL-PU	FDA UDI	Class I	Active
Intensa	IN587WPA-T3	FDA UDI	Class I	Active
Intensa	IN587WDARPA	FDA UDI	Class I	Active
Intensa	748B-ST	FDA UDI	Class I	Active
Intensa	460-FS-AA-TE	FDA UDI	Class I	Active
John Bunn	JB0150-081	FDA UDI	Class I	Active
John Bunn	1398-1#7	FDA UDI	Class II	Active
Intensa	460-FS-OG	FDA UDI	Class I	Active
Intensa	748CB-T2	FDA UDI	Class I	Active
Intensa	IN566DGH8584	FDA UDI	Class I	Active
Intensa	748B-SH	FDA UDI	Class I	Active
Intensa	744CB-WH	FDA UDI	Class I	Active
LabTron	202T	FDA UDI	Class II	Active
Intensa	IN587W454	FDA UDI	Class I	Active
Intensa	744B-AL-BCSW	FDA UDI	Class I	Active
Labtron	400L	FDA UDI	Class I	Active
Intensa	IN587WD6717PA	FDA UDI	Class I	Active
Intensa	IN566DGH6705PA	FDA UDI	Class I	Active
Intensa	IN566DGH8567	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-DO	FDA UDI	Class I	Active
Intensa	460-VI	FDA UDI	Class I	Active
Everest & Jennings	8930188	FDA UDI	Class I	Active
Intensa	IN566G9212	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.