Is this your brand? Sign in to claim ownership.

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 89 of 91

Device	Model / Reference	Registries	Class	Status
Hausted	462CPAST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9201	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G6717	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U409	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U9208	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG1305	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD6724	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG8584	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG6727	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8611	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U8584	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8814	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG6705	EUDAMEDFDA UDI	Class I	Active
Hausted	5E82EYEST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W9212	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD1323	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P9212	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG9208	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD409	EUDAMEDFDA UDI	Class I	Active
Hausted	462GMCST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P401	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG427	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P8584	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601U1323	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G9205	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G1305	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G9201	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W1318	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG6714	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W8533	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG8628	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P1304	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG1325	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587WD9205	EUDAMEDFDA UDI	Class I	Active
Hausted	ESC2EYEST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG9210	EUDAMEDFDA UDI	Class I	Active
Hausted	APC250ST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P6727	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG432	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG454	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG6724	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P1323	EUDAMEDFDA UDI	Class I	Active
Lumex	FR601P9201	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W6705	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566G8567	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W454	EUDAMEDFDA UDI	Class I	Active
Hausted	5E82EYXST	EUDAMEDFDA UDI	Class I	Active
Lumex	FR577RG9212	EUDAMEDFDA UDI	Class I	Active
Lumex	FR587W401	EUDAMEDFDA UDI	Class I	Active
Lumex	FR566DG409	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.