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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Collection Canister; Patient Tubing; PureWick FEC; PureWick Female External Catheter; PureWick Male External Catheter; PureWick MEC; PureWick Urine Collection Accessories Kit; PureWick Urine Collection System; Vacuum Tubing
Classification Name: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
Product Code: NZU
Device Class: 1
Regulation Number: 876.5250
Medical Specialty: Gastroenterology
Registered Establishment Name: BARD SDN. BHD.
Registered Establishment Number: 8040607
Owner/Operator: C. R. Bard, Inc.
Owner/Operator Number: 2212754
Establishment Operations: Contract Manufacturer
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