FDA.reportPublic FDA data

Vitawick Female External Catheter

Primary DI
00850093110014
Brand
Vitawick Female External Catheter
Company
HK DAMISEN TECHNOLOGY CO., LIMITED
Model
VWNG01
Catalog number
VWNG01
Device description
Vitawick Female External Catheter, Home 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
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
00850093110021PackageGS130In Commercial Distribution
00850093110014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850093110021008500931100218500931100210850093110021
00850093110014008500931100148500931100140850093110014

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
+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
false
Expiration date on label
true
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
00850093110038Vitawick Male External CatheterVWND01VWND012026-10-24
00850093110052Vitawick Urine Collection SystemQW300QW3002026-10-24
00850093110069Vitawick Female External CatheterVWNG02VWNG022026-10-24
00850093110083Vitawick Male External CatheterVWND02VWND022026-10-24
00850093110106Vitawick Urine Collection SystemQW400QW4002026-10-24
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
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
00850093110106Vitawick Urine Collection SystemHK 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