4 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014
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.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·May 1, 2013
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
FDA Enforcement
Class II
·Terminated·SteriGear, LLC·July 2, 2014
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 Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.
FDA Enforcement
Class II
·Terminated·C.R. Bard, Inc.·August 16, 2017