FDA.reportPublic FDA data

Hoomsoins Female External Catheter

Primary DI
00860016590250
Brand
Hoomsoins Female External Catheter
Company
HOOMSOINS INC
Model
HS7002
Catalog number
HS7002
Device description
Hoomsoins Female External Catheter, 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
true

Contact Domains#

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
00860016590250PrimaryGS10
00860016602236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016590250008600165902508600165902500860016590250
00860016602236008600166022368600166022360860016602236

GMDN Terms#

Term, Definition table
TermDefinition
Female wearable urinal, single-useA non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
9513652198steven@hoomsoins.care

Regulatory Flags#

DUNS number
147819637
Device count
30
DM exempt
true
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
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
00860016332133HOOMSOINS Urine Collection SystemFM09FM092026-10-08
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
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
00860016332133HOOMSOINS 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
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