FDA.reportPublic FDA data

Carex Health Brands

Primary DI
00815067012558
Brand
Carex Health Brands
Company
Drive Devilbiss Healthcare
Model
FGB341GB THD
Device description
3-IN-1 COMMODE THD 1010590235
Published
2024-02-20
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
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815067012559PackageGS12In Commercial Distribution
00815067012558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081506701255930815067012559
00815067012558008150670125588150670125580815067012558

GMDN Terms#

Term, Definition table
TermDefinition
Commode, manualA non-active, manually-operated transportable device in the form of a chair with a receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors).

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00023601023186CarexDrive Devilbiss HealthcareILS2026-04-29
14895262521362HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
14895262521829SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521048HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521390HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521574HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521727SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521304HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521670HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521779SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521578HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521677HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521721SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521776SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521544HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521551HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521159HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521166HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
00194346699421EquateWAL-MART STORES, INC.ILS2026-04-17
04895262521013HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521020HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521037HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521051HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521068HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521075HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521044HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-13
00023601023827CarexDrive Devilbiss HealthcareILS2026-04-07
00023601658500CarexDrive Devilbiss HealthcareILS2026-01-12
00023601088215CarexDrive Devilbiss HealthcareILS2025-10-16
00023601088208CarexDrive Devilbiss HealthcareILS2025-06-25