FDA.reportPublic FDA data

Surity Female External Catheter

Primary DI
07333387056630
Brand
Surity Female External Catheter
Company
Wellspect AB
Model
38011
Catalog number
3801140
Device description
Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy
Published
2025-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
07333387055312PackageGS13In Commercial Distribution
07333387055329PackageGS130In Commercial Distribution
07333387056821PackageGS116In Commercial Distribution
07333387056838PackageGS13In Commercial Distribution
07333387056630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387055312073333870553127333387055312
07333387055329073333870553297333387055329
07333387056821073333870568217333387056821
07333387056838073333870568387333387056838
07333387056630073333870566307333387056630

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the products in room temperature, 60-77°F

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742USinfo@wellspect.com

Regulatory Flags#

DUNS number
351118942
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333387059730LoFric Origo4401244012002026-08-28
07333387059754LoFric Origo4401444014002026-08-28
07333387059778LoFric Origo4401644016002026-08-28
07333387060446Surity Power Adapter380394038039402026-09-28
07333387055299Surity Urinary Management System380014038001402026-08-18
07333387055305Surity Urinary Management Refresh Kit380024038002402026-08-18
07333387059198Surity Urinary Management System with Battery380034038003402026-08-18
07333387055367Surity Suction Tube380314038031402026-07-13
07333387055398Surity Carbon Filters380344038034402026-07-13
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387055329Surity Female External Catheter38011380112025-12-19
07333387053110LoFric® Origo™4491244912402025-11-24
07333387053127LoFric® Origo™4491444914402025-11-24
07333387053134LoFric® Origo™4491644916402025-11-24
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24
07333387054605LoFric® Origo™4491644916402025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016624702CDCICV Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016624719CDCICV Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016624733CDCICV Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016624757Strvivo Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016624764Strvivo Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016624788Strvivo Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625808CDCICV Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625815CDCICV Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625839CDCICV Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625853CDCICV Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625860CDCICV Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625884CDCICV Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625907Strvivo Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625914Strvivo Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625938Strvivo Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625952Strvivo Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625969Strvivo Female External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00860016625983Strvivo Male External CatheterShenzhen Weirui Technology Co., LtdNZU2026-10-14
00850067913290NexaFlowHR PHARMACEUTICALS INC.NZU2026-10-13
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