FDA.reportPublic FDA data

Surity Power Adapter

Primary DI
07333387060446
Brand
Surity Power Adapter
Company
Wellspect AB
Model
3803940
Catalog number
3803940
Device description
1 Power adapter, Installation guide
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
false

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
07333387060446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387060446073333870604467333387060446

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
false
Serial number
true
Manufacturing date on label
false
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
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
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
07333387054353LoFric® Origo™4471244712402025-07-25
07333387054377LoFric® Origo™4471444714402025-07-25
07333387054421LoFric® Origo™4471644716402025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333387055367Surity Suction TubeWellspect ABNZU2026-07-13
07333387055398Surity Carbon FiltersWellspect ABNZU2026-07-13
00801741231025PureWickC. R. Bard, Inc.NZU2026-05-07
00801741234514PureWickC. R. Bard, Inc.NZU2026-05-07
00801741231537PureWickC. R. Bard, Inc.NZU2026-05-06
10801741239219PureWickC. R. Bard, Inc.NZU2026-05-05
07333387056623Surity Male External CatheterWellspect ABNZU2026-04-27
00801741231001PureWickC. R. Bard, Inc.NZU2026-02-06
00801741231018PureWickC. R. Bard, Inc.NZU2026-02-06
07333387056630Surity Female External CatheterWellspect ABNZU2025-12-19
07333387055329Surity Female External CatheterWellspect ABNZU2025-12-19
10816286021151BOEHRINGER® CareDry™ Male SystemBOEHRINGER LABORATORIES, LLCNZU2024-12-31
20816286021158BOEHRINGER® CareDry™ Male SystemBOEHRINGER LABORATORIES, LLCNZU2024-12-31
00801741226960PureWickC. R. Bard, Inc.NZU2024-07-29
00801741226984PureWickC. R. Bard, Inc.NZU2024-07-29
10801741226967PureWickC. R. Bard, Inc.NZU2024-07-29
10801741226981PureWickC. R. Bard, Inc.NZU2024-07-29
00801741226465PureWickC. R. Bard, Inc.NZU2024-05-31
00801741226953PureWickC. R. Bard, Inc.NZU2024-05-31
10801741226462PureWickC. R. Bard, Inc.NZU2024-05-31
10801741226950PureWickC. R. Bard, Inc.NZU2024-05-31
07290109270203UriCap Base kit+ box of 30TILLA CARE LTDNZU2024-04-02
07290109270210UriCap Female + TILLA CARE LTDNZU2024-04-02
07290109270227Home Sample Kits (box of 5)TILLA CARE LTDNZU2024-04-02
07290109270234Home Base Kit (30-Day Supply)TILLA CARE LTDNZU2024-04-02
10816286021144BOEHRINGER® CareDry™ SystemBOEHRINGER LABORATORIES, LLCNZU2023-12-29
20816286021141BOEHRINGER® CareDry™ SystemBOEHRINGER LABORATORIES, LLCNZU2023-12-29
07290109270197Tube Connector TILLA CARE LTDNZU2023-10-02
00801741219153PureWick MaleC. R. Bard, Inc.NZU2022-08-01
10801741219150PureWick MaleC. R. Bard, Inc.NZU2022-08-01