FDA.reportPublic FDA data

LUMEX

Primary DI
M368US0218PKG1
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
US0218-PKG
Device description
Patriot Homecare Bed
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368US0218PKG1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric home bedA mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
114107329
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344215454MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215461MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215478MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344176618MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-16
10197344176601MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-13
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00841447116295Invacare® Bed Extender HeadspringINVACARE CORPORATIONLLI2025-12-05
05060631842580Cosyfit standard/Extra WideSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-21
05060631840036Siesta SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840166Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840173Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840180Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840364Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841101Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841194Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841200Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631842610Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843082Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843099Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843105Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843129Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843136Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843143Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840104Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840111Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840128Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840210Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840227Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12