MedtechSourcebook

Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) contract manufacturers

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

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

FDA device name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product code
KDI (FDA product classification database)
Device class
Class II
Regulation
21 CFR 876.5860
Classification panel
Gastroenterology and urology
FDA flags
life-sustaining or life-supporting

Where they are

California 2 · Minnesota 2 · Texas 2 · South Carolina 1 · Utah 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ISOMEDIX OPERATIONS INC.1047843Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Orthopedic +13 moreSpartanburg, SCNot verifiedOct 21, 2026
Isomedix Operations, Inc2032098Contract sterilizerOrthopedic; General and plastic surgery; General hospital +12 moreOntario, CANot verifiedOct 21, 2026
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
KLUGE DESIGN INC.3003661577Contract manufacturerGastroenterology and urology; Cardiovascular; General and plastic surgery +1 moreRogers, MNNot verifiedOct 21, 2026
Sterigenics U.S., LLC1721676Contract sterilizerCardiovascular; Orthopedic; General and plastic surgery +12 moreSalt Lake City, UTNot verifiedOct 21, 2026
Sterigenics US LLC1649518Contract sterilizerOrthopedic; General and plastic surgery; General hospital +13 moreFort Worth, TXNot verifiedOct 21, 2026
Sterigenics US LLC3004111573Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreGrand Prairie, TXNot verifiedOct 21, 2026
Synergy Health AST, LLC3012102437Contract sterilizerCardiovascular; General and plastic surgery; Orthopedic +6 morePetaluma, CANot verifiedOct 21, 2026

Related gastroenterology and urology product codes