FDA.reportPublic FDA data

PureWick

Primary DI
00801741231537
Brand
PureWick
Company
C. R. Bard, Inc.
Model
PWKIT03H
Catalog number
PWKIT03H
Device description
PureWick Urine Collection System
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00801741231537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741231537008017412315378017412315370801741231537

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
+1(844)823-5433BMD.CS.support@bd.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741236563SURESTEPSSPEDINTS08SSPEDINTS082026-10-06
00801741236570SURESTEPSSPEDINTS10SSPEDINTS102026-10-06
00801741236587SURESTEPSSINTL15SSINTL152026-10-06
00801741236594SURESTEPSSINTL16CSSINTL16C2026-10-06
00801741236600SURESTEPSSINTS14SSINTS142026-10-06
00801741236617SURESTEPSSINTS14CSSINTS14C2026-10-06
00801741236624SURESTEPSSINTS16SSINTS162026-10-06
00801741236631SURESTEPSSINTS16CSSINTS16C2026-10-06
00801741045943Bard® DigniShield® Stool Management SystemSMS002SMS0022016-08-25
00801741050930Fecal Containment Device1900111900112020-09-22
00801741113147Bard® DigniShield® Stool Management System with ENFit™ENSMS002ENSMS0022016-11-03
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10

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
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