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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
LinkedIn
—
Facebook
—
Phone
+17703684700
PRRC Contact
Amy Piccini
EUDAMED SRN
US-MF-000002167
FDA FEI Number
2427360
DUNS Number
—

Catalogue (4538)

Page 34 of 91
DeviceModel / ReferenceRegistriesClassStatus
Hausted 4600-AA-DW-PU
FDA UDI
Class IActive
Hausted 4600-AA-VI
FDA UDI
Class IActive
Everest & Jennings 8920208
FDA UDI
Class IActive
Lumiscope 100-040ORC
FDA UDI
Class IIActive
Intensa 748CB-WH
FDA UDI
Class IActive
Intensa 460-AA-DW-T3
FDA UDI
Class IActive
Intensa IN587WH1318PA
FDA UDI
Class IActive
Intensa 620-MO
FDA UDI
Class IActive
Grafco 2849
FDA UDI
Class IActive
Lumex UP894
FDA UDI
Class IActive
Lumex FR597G9208
FDA UDI
Class IActive
Hausted 4600-FS-AA-PS-BU
FDA UDI
Class IActive
Intensa 460-FS-PS-BU
FDA UDI
Class IActive
Hausted 4600-BU
FDA UDI
Class IActive
Intensa IN587WD1304PA
FDA UDI
Class IActive
Lumex FR566G8602PA
FDA UDI
Class IActive
Intensa IN587WDH1318
FDA UDI
Class IActive
Grafco 2748
FDA UDI
Class IActive
Grafco GF1843
FDA UDI
Class IActive
Intensa 744-T1
FDA UDI
Class IActive
Lumex FR587WH6727PA
FDA UDI
Class IActive
John Bunn GF64232
FDA UDI
Class IActive
Lumex FR577RGH6724PA
FDA UDI
Class IActive
Intensa 460-PL
FDA UDI
Class IActive
Intensa 744-BU
FDA UDI
Class IActive
Intensa 460-AA-TL
FDA UDI
Class IActive
Lumex DM81G
FDA UDI
Class IActive
Lumex FR587WDH1305
FDA UDI
Class IActive
Lumex FR577RGH9210
FDA UDI
Class IActive
Intensa 460-AA-DW-T10
FDA UDI
Class IActive
Intensa IN587WDH1325
FDA UDI
Class IActive
Everest & Jennings 90763566
FDA UDI
Class IActive
Intensa IN566DG9212PA
FDA UDI
Class IActive
Lumex UPH864
FDA UDI
Class IActive
Everest & Jennings 3F012220
FDA UDI
Class IActive
Lumex FR601PLHO427
FDA UDI
Class IActive
Intensa IN597P1311
FDA UDI
Class IActive
Intensa 460-AA-PS-T3
FDA UDI
Class IActive
Lumex FR587WH9214PA
FDA UDI
Class IActive
Intensa IN577RGH1318
FDA UDI
Class IActive
LabTron 200BK-T
FDA UDI
Class IIActive
Hausted 4600-PM
FDA UDI
Class IActive
Intensa IN601PHBT
FDA UDI
Class IActive
Grafco GF-TT5
FDA UDI
Class IIActive
John Bunn 3255-5
FDA UDI
Class IIActive
Lumex FR566GH9214PA
FDA UDI
Class IActive
Grafco 1697-1M
FDA UDI
Class IActive
Intensa 460-T2
FDA UDI
Class IActive
Intensa IN577RG454PA
FDA UDI
Class IActive
Lumex FR566DGH409
FDA UDI
Class IActive

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Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.

DateRecall No.ClassStatusReason
Mar 24, 2021Z-1353-2021—terminated

The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.

Sep 30, 2016Z-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, 2009Z-0139-2010—terminated

Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.