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Panels › Gastroenterology, Urology › Product code KNX · Class 2

Collector, Urine, (And Accessories) For Indwelling Catheter

Regulation 876.5250

0510(k)s in 12 months (206 all time)
2recalls in 12 months (21 all time)
9recalls that name a 510(k)
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Top companies in KNX

DateFirm and productCodeLinked 510(k)
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex IC Complete Care REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex IC Complete C
Open, Classified
KNXNone listed
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067 10801741121064 SureStep" Foley Tray System Complete Care Add-A-Foley
Open, Classified
KNXNone listed
Feb 16, 2024Cardinal Health 200, LLC
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URIN
Open, Classified
KNXNone listed
Jan 14, 2019Teleflex Medical
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Terminated
KNXNone listed
Jan 14, 2019Teleflex Medical
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Terminated
KNXNone listed
Jun 2, 2017C.R. Bard, Inc.
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usa
Terminated
KNXNone listed
Jul 11, 2016C.R. Bard, Inc.
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Terminated
KNXNone listed
Jun 29, 2016C.R. Bard, Inc.
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Terminated
KNXNone listed
Sep 3, 2015Customed, Inc
UROLOGY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KNXNone listed
Sep 3, 2015Customed, Inc
UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KNXK902886
Sep 3, 2015Customed, Inc
UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KNXK962652
Sep 3, 2015Customed, Inc
UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KNXK962652
Sep 3, 2015Customed, Inc
FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KNXK962652
Sep 3, 2015Customed, Inc
UROLOGY CUSTOMED PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
KNXK962652
Apr 1, 2015C.R. Bard, Inc.
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Terminated
KNXNone listed
Apr 22, 2013Teleflex Medical
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
Terminated
KNXNone listed
May 27, 2011Covidien LP
URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada only) Intended use:Collector urine from male patients (and accessories) for indwelling catheter
Terminated
KNXK770789
May 27, 2011Covidien LP
URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male patients (and accessories) for indwelli
Terminated
KNXK770789
May 27, 2011Covidien LP
URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732000 Intended use: Collector urine from male patients (and accessories) for indwelling
Terminated
KNXK770789
Mar 23, 2005Teleflex Medical, Inc.
Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, G
Terminated
KNXNone listed
Mar 23, 2005Teleflex Medical, Inc.
Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1
Terminated
KNXK871387

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