MedtechSourcebook

Accessory Equipment, Cardiopulmonary Bypass (KRI) contract manufacturers

7 US facilities list FDA product code KRI as a contract manufacturer (2) or contract sterilizer (5).

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

FDA device name
Accessory Equipment, Cardiopulmonary Bypass
Product code
KRI (FDA product classification database)
Device class
Class I
Regulation
21 CFR 870.4200
Classification panel
Cardiovascular

Where they are

Tennessee 2 · Colorado 1 · Illinois 1 · Minnesota 1 · New Jersey 1 · Texas 1

All 7 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
DeRoyal Industries, Inc.1054241Contract sterilizerGeneral and plastic surgery; General hospital; Gastroenterology and urology +14 moreNew Tazewell, TNNot verifiedOct 21, 2026
DEROYAL INDUSTRIES, INC.1055236Contract sterilizerGeneral and plastic surgery; General hospital; Gastroenterology and urology +14 moreNew Tazewell, TNNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC1643817Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +14 moreEl Paso, TXNot verifiedOct 21, 2026
KLUGE DESIGN INC.3003661577Contract manufacturerGastroenterology and urology; Cardiovascular; General and plastic surgery +1 moreRogers, MNNot verifiedOct 21, 2026
LYNX Medical NJ2244478Contract sterilizerOrthopedic; General and plastic surgery; General hospital +9 moreFranklin, NJNot verifiedOct 21, 2026
MEDLINE INDUSTRIES, LP (Northpoint Services)1422634Contract sterilizerGeneral and plastic surgery; General hospital; Cardiovascular +10 moreWaukegan, ILNot verifiedOct 21, 2026
MULTISOURCE MANUFACTURING LLC3010009632Contract manufacturerCardiovascular; Neurology; Anesthesiology +2 moreLongmont, CONot verifiedOct 21, 2026

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