FDA.reportPublic FDA data

CDCICV Female External Catheter

Primary DI
00860016625815
Brand
CDCICV Female External Catheter
Company
Shenzhen Weirui Technology Co., Ltd
Model
CDC302
Catalog number
CDC302
Device description
CDCICV Female External Catheter, Comfort Edition
Published
2026-10-14
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
00860016625822PackageGS130In Commercial Distribution
00860016625815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016625822008600166258228600166258220860016625822
00860016625815008600166258158600166258150860016625815

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
+1 332-201-5192info@zenclothe.com

Regulatory Flags#

DUNS number
615965610
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
00860016624702CDCICV Urine Collection SystemCDH201CDH2012026-10-14
00860016624719CDCICV Female External CatheterCDH202CDH2022026-10-14
00860016624733CDCICV Male External CatheterCDH203CDH2032026-10-14
00860016624757Strvivo Urine Collection SystemSOH301SOH3012026-10-14
00860016624764Strvivo Female External CatheterSOH302SOH3022026-10-14
00860016624788Strvivo Male External CatheterSOH303SOH3032026-10-14
00860016625808CDCICV Urine Collection SystemCDC301CDC3012026-10-14
00860016625839CDCICV Male External CatheterCDC303CDC3032026-10-14
00860016625853CDCICV Urine Collection SystemCDE401CDE4012026-10-14
00860016625860CDCICV Female External CatheterCDE402CDE4022026-10-14
00860016625884CDCICV Male External CatheterCDE403CDE4032026-10-14
00860016625907Strvivo Urine Collection SystemSOC401SOC4012026-10-14
00860016625914Strvivo Female External CatheterSOC402SOC4022026-10-14
00860016625938Strvivo Male External CatheterSOC403SOC4032026-10-14
00860016625952Strvivo Urine Collection SystemSOE501SOE5012026-10-14
00860016625969Strvivo Female External CatheterSOE502SOE5022026-10-14
00860016625983Strvivo Male External CatheterSOE503SOE5032026-10-14
00860016515802Strvivo Urine Collection SystemSO201SO2012026-09-30
00860016515819CDCICV Female External CatheterCD102CD1022026-09-30
00860016515833CDCICV Male External CatheterCD103CD1032026-09-30

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
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
00860016590229Hoomsoins Female External CatheterHOOMSOINS INCNZU2026-10-08