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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 85 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	460-FS-PS-T3	FDA UDI	Class I	Active
LUMES Essentials	81242	FDA UDI	Class I	Active
Intensa	IN587WDH8516	FDA UDI	Class I	Active
Intensa	748-COM-SW	FDA UDI	Class I	Active
Intensa	IN587WD1318	FDA UDI	Class I	Active
Intensa	460-AA-PS-WW	FDA UDI	Class I	Active
Intensa	748CB-AL	FDA UDI	Class I	Active
Intensa	IN587WDTL	FDA UDI	Class I	Active
Grafco	1698	FDA UDI	Class I	Active
Intensa	420-EO-T5	FDA UDI	Class I	Active
Grafco	2771	FDA UDI	Class I	Active
Intensa	IN587WD9210PA	FDA UDI	Class I	Active
Intensa	IN601PHWH	FDA UDI	Class I	Active
Intensa	IN587W1318	FDA UDI	Class I	Active
Intensa	460-AA-OG	FDA UDI	Class I	Active
Intensa	420-EO-NO	FDA UDI	Class I	Active
Intensa	IN566GH401	FDA UDI	Class I	Active
Gendron	GT4XL	FDA UDI	Class II	Active
Gendron	7150P180	FDA UDI	Class I	Active
Intensa	420-DW-PL	FDA UDI	Class I	Active
Grafco	9679	FDA UDI	Class I	Active
Intensa	IN566DGH6705	FDA UDI	Class I	Active
Basic American Medical Products	ZG78174	FDA UDI	Class II	Active
Intensa	744B-PM	FDA UDI	Class I	Active
Intensa	IN597PVI	FDA UDI	Class I	Active
Intensa	420-DB	FDA UDI	Class I	Active
Everest & Jennings	90835070J	FDA UDI	Class I	Active
Intensa	IN587WDWHPA	FDA UDI	Class I	Active
Intensa	IN577RGHTEPA	FDA UDI	Class I	Active
Everest & Jennings	3E050150	FDA UDI	Class I	Active
Intensa	420-DW-PM	FDA UDI	Class I	Active
Intensa	IN566DGHGR	FDA UDI	Class I	Active
Grafco	2734	FDA UDI	Class I	Active
Intensa	IN587WVI	FDA UDI	Class I	Active
Intensa	748B-T1	FDA UDI	Class I	Active
Intensa	IN566DG8602	FDA UDI	Class I	Active
Intensa	460-FS-PS-AR	FDA UDI	Class I	Active
Intensa	IN587WHOGPA	FDA UDI	Class I	Active
Intensa	IN566GH1304	FDA UDI	Class I	Active
Intensa	620-DO	FDA UDI	Class I	Active
Intensa	460-FS-AA-T4	FDA UDI	Class I	Active
Everest & Jennings	20252218B	FDA UDI	Class I	Active
Intensa	IN587WDH8604	FDA UDI	Class I	Active
Intensa	744CB-NO	FDA UDI	Class I	Active
Intensa	IN587WH9214PA	FDA UDI	Class I	Active
Intensa	IN566DGGR	FDA UDI	Class I	Active
Intensa	748B-WW	FDA UDI	Class I	Active
Intensa	IN566GHMOPA	FDA UDI	Class I	Active
Intensa	460-FS-TL	FDA UDI	Class I	Active
Intensa	IN566GH9207	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.