FDA.reportPublic FDA data

LUMEX

Primary DI
M3687109A20
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
7109A-2
Catalog number
7109A-2
Device description
BARIATRIC FOLDING COMMODE
Published
2021-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
INNChair, Adjustable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3687109A21PrimaryHIBCC0
M3687109A20Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CommodeA special kind of chair with a built-in receptacle for toileting away from a bathroom or fixed toilet and is designed for persons with a disability. Included in the GMDN code are sanichairs and commode chairs used for showering. It may or may not be supplied with wheels (castors).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
132016168
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M36823562X1GRAHAM FIELD2356-2X 2026-02-20
M36823572A1GRAHAM FIELD2357-2A 2026-02-20
M3682360A1GRAHAM FIELD2360A 2026-02-20
M3682362X2GRAHAM FIELD2362X2026-02-20
M368ESC2EYESTMBX1HAUSTEDESC2EYEST-MB-X2026-02-02
M368H0678972HAUSTEDH0678972025-10-31
M368ALX361AMERILUXALX362025-12-11
M368ALX421AMERILUXALX422025-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
00628758009009ZwimRaz Design IncINN2024-11-06
00850010988702Mor-Medical New EraMoroles Investments, LLCINN2024-07-16
10197344018840MEDLINEMEDLINE INDUSTRIES, INC.INN2024-06-26
00628758001027JazRaz Design IncINN2024-06-12
00628758002024JazRaz Design IncINN2024-06-12
05056235203858Jenx JENX LIMITEDINN2024-05-10
05056235203865Jenx JENX LIMITEDINN2024-05-10
05056235203872Jenx JENX LIMITEDINN2024-05-10
05056235203889Jenx JENX LIMITEDINN2024-05-10
05056235203896Jenx JENX LIMITEDINN2024-05-10
05056235203902Jenx JENX LIMITEDINN2024-05-10
05056235203919Jenx JENX LIMITEDINN2024-05-10