MedtechSourcebook

Catheter, Hemodialysis, Triple Lumen, Non-Implanted (NIE) contract manufacturers

8 US facilities list FDA product code NIE as a contract manufacturer (1) or contract sterilizer (7).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Product code
NIE (FDA product classification database)
Device class
Class II
Regulation
21 CFR 876.5540
Classification panel
Gastroenterology and urology
FDA flags
life-sustaining or life-supporting

Where they are

California 2 · Georgia 2 · Massachusetts 1 · New York 1 · Texas 1 · Utah 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
C.R. BARD, INC.1018233Contract sterilizerGastroenterology and urology; Cardiovascular; General and plastic surgery +4 moreCovington, GANot verifiedOct 21, 2026
C.R. BARD, INC.3006082230Contract sterilizerGastroenterology and urology; Cardiovascular; General and plastic surgery +4 moreMadison, GANot verifiedOct 21, 2026
Isomedix Operations Inc3009888344Contract sterilizerGastroenterology and urology; General and plastic surgery; General hospital +13 moreEl Paso, TXNot verifiedOct 21, 2026
Isomedix Operations, Inc.2030624Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +11 moreTemecula, CANot verifiedOct 21, 2026
Paragon Medical - Mansfield, Bridgemedica3007544634Contract manufacturerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +3 moreMansfield, MANot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026
Sterigenics U.S., LLC1721676Contract sterilizerCardiovascular; Orthopedic; General and plastic surgery +12 moreSalt Lake City, UTNot verifiedOct 21, 2026
Sterigenics US LLC2011171Contract sterilizerCardiovascular; General and plastic surgery; General hospital +13 moreLos Angeles, CANot verifiedOct 21, 2026

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