FDA.reportPublic FDA data

Gendron

Primary DI
M368GS4842DNS1
Brand
Gendron
Company
GF HEALTH PRODUCTS, INC.
Model
GS4842DNS
Catalog number
GS4842DNS
Device description
Maxirest Bed, Bariatric Adj Deck
Published
2020-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368GS4842DNS1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Contacts#

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

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
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
04719876190055TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190277TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190574TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190581TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190598TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190932TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191588TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191595TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191625TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191663TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
06977918410150SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-10
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
00840117324541Bariatric Full Electric Home Care Bed 54"Dynarex CorporationFNL2023-12-29
08592654283455Eleganza 5L I N E T spol. s r.o.FNL2022-12-21
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"Dynarex CorporationFNL2022-11-21
00840117324558Dynarex Bari + Max Bariatric Full Electric Home Care Bed 54"Dynarex CorporationFNL2022-11-21
00840117324718Dynarex Bari + Max Bariatric Full Electric Home Care Bed 54" Foot DeckDynarex CorporationFNL2022-11-21
M676MC7WSTMLB0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNL2022-11-08
10190676005557POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676006547POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676005588POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
07613327584745Sidekick SpraySTRYKER CORPORATIONFNL2022-02-28
00840117302891Long-Term Care Bed, D100Dynarex CorporationFNL2021-02-03
00840117302907Long Term Care Bed, D200Dynarex CorporationFNL2021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low BedDynarex CorporationFNL2021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low BedDynarex CorporationFNL2021-02-03
00616784040424Bariatric Full Electric Home Care Bed Head Deck 42"Dynarex CorporationFNL2021-02-02
00616784040431Home Care BedDynarex CorporationFNL2021-02-02
00616784040523Bariatric HD Home Care Full Electric Bed, Head Deck, 48"Dynarex CorporationFNL2021-02-02