FDA-Device2013-05-01Class II

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.

Teleflex Medical
Hazard

Sterile packaging may be compromised.

Sold states
Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.
Affected count
190,103
Manufactured in
4024 Stirrup Creek Dr, Durham, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2013

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