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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Peristeen Irrigation Accessory Unit; Peristeen Irrigation Rectal Catheter; Peristeen Irrigation TubePeristeen Irrigation Tube; Peristeen Plus balloon catheter; Peristeen Plus Transanal Irrigation System; Peristeen Plus tube; Peristeen System Strap; Peristeen Transanal Irrigation System; Peristeen™ Anal Irrigation System
Classification Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Product Code: KNT
Device Class: 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST A/S
Registered Establishment Number: 9610694
Premarket Submission Number: K140310
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Specification Developer
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