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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 73 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	4600-AA-FS-PU	FDA UDI	Class I	Active
Lumex	FR566DG1318PA	FDA UDI	Class I	Active
Intensa	744CB-TL	FDA UDI	Class I	Active
Lumex	FR577RGH1323	FDA UDI	Class I	Active
Intensa	748CB-T7	FDA UDI	Class I	Active
Hausted	4600-FS-PS-AL	FDA UDI	Class I	Active
Intensa	IN601PWH	FDA UDI	Class I	Active
Intensa	IN566DGHWH	FDA UDI	Class I	Active
Hausted	4200-DW-AQ	FDA UDI	Class I	Active
Intensa	IN587WD6725PA	FDA UDI	Class I	Active
Hausted	4200-DW-BL	FDA UDI	Class I	Active
Intensa	IN597G1325	FDA UDI	Class I	Active
Hausted	4600-AA-DW-NA	FDA UDI	Class I	Active
Lumiscope	100-001N	FDA UDI	Class II	Active
Intensa	744-WW	FDA UDI	Class I	Active
Intensa	IN587WHPMPA	FDA UDI	Class I	Active
Basic American Medical Products	ZZA9917406	FDA UDI	Class II	Active
Intensa	IN577RGH409PA	FDA UDI	Class I	Active
Hausted	4600-FL-ST	FDA UDI	Class I	Active
Hausted	4600-PL	FDA UDI	Class I	Active
Intensa	420-EO-NA	FDA UDI	Class I	Active
Intensa	IN566G1315	FDA UDI	Class I	Active
Intensa	IN587WDH9207PA	FDA UDI	Class I	Active
Intensa	420-T3	FDA UDI	Class I	Active
Hausted	4600-FS-PS-TE	FDA UDI	Class I	Active
Intensa	IN601PWW	FDA UDI	Class I	Active
Intensa	IN587WHGRPA	FDA UDI	Class I	Active
Lumiscope	100-040GRP	FDA UDI	Class II	Active
Intensa	620-DA-TL	FDA UDI	Class I	Active
Lumex	FR587WH9210	FDA UDI	Class I	Active
Lumex	FR587WHO427	FDA UDI	Class I	Active
Intensa	460-AA-PS-T9	FDA UDI	Class I	Active
Intensa	IN587WH8604PA	FDA UDI	Class I	Active
Intensa	620-DA-T2	FDA UDI	Class I	Active
Intensa	420-WW	FDA UDI	Class I	Active
Lumex	FR566G401PA	FDA UDI	Class I	Active
Hausted	4600-DW-AL	FDA UDI	Class I	Active
Grafco	GF-45	FDA UDI	Class II	Active
Intensa	460-AA-PS-DO	FDA UDI	Class I	Active
Everest & Jennings	3E050230	FDA UDI	Class I	Active
Grafco	2684	FDA UDI	Class I	Active
Intensa	420-EO-SH	FDA UDI	Class I	Active
Intensa	460-DW-T7	FDA UDI	Class I	Active
Intensa	IN587WOGPA	FDA UDI	Class I	Active
Lumex	DSHC70001	FDA UDI	Class I	Active
Intensa	744CB-ST	FDA UDI	Class I	Active
Lumex	LCMP100	FDA UDI	Class II	Active
Lumex	FR577RG1311PA	FDA UDI	Class I	Active
Intensa	IN587WD-T2	FDA UDI	Class I	Active
LabTron	180	FDA UDI	Class II	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.