FDA.reportPublic FDA data

Vitawick Urine Collection System

Primary DI
00850093110106
Brand
Vitawick Urine Collection System
Company
HK DAMISEN TECHNOLOGY CO., LIMITED
Model
QW400
Catalog number
QW400
Device description
Vitawick Urine Collection System , Everyday Care Edition
Published
2026-10-24
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

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
00850093110106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850093110106008500931101068500931101060850093110106

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.

Contacts#

Phone, Email table
PhoneEmail
+16462016683support@vitawick.com

Regulatory Flags#

DUNS number
687187825
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850093110007Vitawick Urine Collection SystemQW200QW2002026-10-24
00850093110014Vitawick Female External CatheterVWNG01VWNG012026-10-24
00850093110038Vitawick Male External CatheterVWND01VWND012026-10-24
00850093110052Vitawick Urine Collection SystemQW300QW3002026-10-24
00850093110069Vitawick Female External CatheterVWNG02VWNG022026-10-24
00850093110083Vitawick Male External CatheterVWND02VWND022026-10-24
00850093110113Vitawick Female External CatheterVWNG03VWNG032026-10-24
00850093110137Vitawick Male External CatheterVWND03VWND032026-10-24
00860016449404Vitawick Male External CatheterNXND01NXND012026-09-05
00860016449411Vitawick Urine Collection SystemQW100QW1002026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850093110007Vitawick Urine Collection SystemHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110014Vitawick Female External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110038Vitawick Male External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110052Vitawick Urine Collection SystemHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110069Vitawick Female External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110083Vitawick Male External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110113Vitawick Female External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
00850093110137Vitawick Male External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-10-24
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