FDA.reportPublic FDA data

HOOMSOINS Urine Collection System

Primary DI
00860016332133
Brand
HOOMSOINS Urine Collection System
Company
HOOMSOINS INC
Model
FM09
Catalog number
FM09
Device description
HOOMSOINS Urine Collection System,Non-Battery, Home use
Published
2026-10-08
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

Product Codes#

Code, Name table
CodeName
NZUCollector, Urine, Powered, Non Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZUCollector, Urine, Powered, Non Indwelling CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016332133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016332133008600163321338600163321330860016332133

GMDN Terms#

Term, Definition table
TermDefinition
Bed incontinence systemAn assembly of devices intended to be fitted to a home bed and used by an incontinent/bed-bound patient for the removal of excrement and subsequent washing during bed occupancy. It includes a mains electricity (AC-powered) air/water pumping unit with heated water reservoir; waste container; and controls connected via relevant tubing to a suction cup, which conforms to the patient’s perineum. It may also include a bed washing/suction hose for general body cleaning, and a shaped mattress to accommodate the system tubing. Waste (i.e., faeces, urine, and waste water) is intended to be removed through suction; a supply of water and air is used to clean and dry the patient after waste removal.

Regulatory Flags#

DUNS number
147819637
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00860016332119HOOMSOINS Urine Collection SystemFM02FM022026-10-08
00860016332126HOOMSOINS Urine Collection SystemFM07FM072026-10-08
00860016332140Hoomsoins Female External CatheterHS7001HS70012026-10-08
00860016332157Hoomsoins Female External CatheterHS7002HS70022026-10-08
00860016332164Hoomsoins Female External CatheterHS7007HS70072026-10-08
00860016332171Hoomsoins Female External CatheterHS80082HS800822026-10-08
00860016332188Hoomsoins Female External CatheterHS80089AHS80089A2026-10-08
00860016332195Hoomsoins Male External CatheterHS6002HS60022026-10-08
00860016590205Hoomsoins Male External CatheterHS80081HS800812026-10-08
00860016590212Hoomsoins Male External CatheterHS6001HS60012026-10-08
00860016590229Hoomsoins Female External CatheterHS80082HS800822026-10-08
00860016590236Hoomsoins Female External CatheterHS80089AHS80089A2026-10-08
00860016590243Hoomsoins Female External CatheterHS7001HS70012026-10-08
00860016590250Hoomsoins Female External CatheterHS7002HS70022026-10-08
00860016590267Hoomsoins Male External CatheterHS6001HS60012026-10-08
00860016590274HOOMSOINS Collection canisterHS80075HS800752026-10-08
00860016590281Hoomsoins Female External CatheterHS7003HS70032026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016332119HOOMSOINS Urine Collection SystemHOOMSOINS INCNZU2026-10-08
00860016332126HOOMSOINS Urine Collection SystemHOOMSOINS INCNZU2026-10-08
00860016332140Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016332157Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016332164Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016332171Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016332188Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016332195Hoomsoins Male External CatheterHOOMSOINS INCNZU2026-10-08
00860016590205Hoomsoins Male External CatheterHOOMSOINS INCNZU2026-10-08
00860016590212Hoomsoins Male External CatheterHOOMSOINS INCNZU2026-10-08
00860016590229Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016590236Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016590243Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016590250Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016590267Hoomsoins Male External CatheterHOOMSOINS INCNZU2026-10-08
00860016590274HOOMSOINS Collection canisterHOOMSOINS INCNZU2026-10-08
00860016590281Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08
00860016515802Strvivo Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-09-30
00860016515819CDCICV Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-09-30
00860016515833CDCICV Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-09-30
00860016515857CDCICV Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-09-30
00860016515864Strvivo Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-09-30
00860016515888Strvivo Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-09-30
07333387060446Surity Power AdapterWellspect ABNZU2026-09-28
00810053920251SecureSoftCOMPACTCATH, INC.NZU2026-09-24
00860016449404Vitawick Male External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-09-05
00860016449411Vitawick Urine Collection SystemHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-09-04
07333387055299Surity Urinary Management SystemWellspect ABNZU2026-08-18
07333387055305Surity Urinary Management Refresh KitWellspect ABNZU2026-08-18
07333387059198Surity Urinary Management System with BatteryWellspect ABNZU2026-08-18