FDA.reportPublic FDA data

Surity Carbon Filters

Primary DI
07333387055398
Brand
Surity Carbon Filters
Company
Wellspect AB
Model
3803440
Catalog number
3803440
Device description
4 Carbon filter
Published
2026-07-13
Public version status
Update
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
07333387055398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387055398073333870553987333387055398

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.

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
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
true
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
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
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
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
07333387052953LoFric® Origo™4471244712402025-07-25
07333387053059LoFric® Origo™4471444714402025-07-25
07333387053066LoFric® Origo™4471644716402025-07-25

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
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