FDA.reportPublic FDA data

CDCICV Male External Catheter

Primary DI
00860016515833
Brand
CDCICV Male External Catheter
Company
Shenzhen Weirui Technology Co., Ltd
Model
CD103
Catalog number
CD103
Device description
CDCICV Male External Catheter
Published
2026-09-30
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
00860016515840PackageGS130In Commercial Distribution
00860016515833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016515840008600165158408600165158400860016515840
00860016515833008600165158338600165158330860016515833

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-useA device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. 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
00860016515802Strvivo Urine Collection SystemSO201SO2012026-09-30
00860016515819CDCICV Female External CatheterCD102CD1022026-09-30
00860016515857CDCICV Urine Collection SystemCD101CD1012026-09-30
00860016515864Strvivo Female External CatheterSO202SO2022026-09-30
00860016515888Strvivo Male External CatheterSO203SO2032026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016515802Strvivo Urine Collection SystemShenzhen Weirui Technology Co., LtdNZU2026-09-30
00860016515819CDCICV Female 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
07333387059198Surity Urinary Management System with BatteryWellspect ABNZU2026-08-18
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