MedtechSourcebook

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) contract manufacturers

8 US facilities list FDA product code KFM as a contract manufacturer (2) or contract sterilizer (6).

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

FDA device name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Product code
KFM (FDA product classification database)
Device class
Class II
Regulation
21 CFR 870.4360
Classification panel
Cardiovascular

Where they are

California 2 · Illinois 1 · Minnesota 1 · Missouri 1 · New York 1 · Pennsylvania 1 · Virginia 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
KLUGE DESIGN INC.3003661577Contract manufacturerGastroenterology and urology; Cardiovascular; General and plastic surgery +1 moreRogers, MNNot verifiedOct 21, 2026
LYNX Medical Pennsylvania2528981Contract sterilizerOrthopedic; Gastroenterology and urology; Cardiovascular +8 moreErie, PANot verifiedOct 21, 2026
MEDLINE INDUSTRIES, LP (Northpoint Services)1422634Contract sterilizerGeneral and plastic surgery; General hospital; Cardiovascular +10 moreWaukegan, ILNot verifiedOct 21, 2026
MIDWEST STERILIZATION CORP.1928237Contract sterilizerGeneral and plastic surgery; Cardiovascular; General hospital +14 moreJackson, MONot verifiedOct 21, 2026
STERILIZATION SERVICES OF VIRGINIA1123137Contract manufacturerGeneral and plastic surgery; Cardiovascular; General hospital +9 moreRichmond, VANot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026
Sterigenics U.S., LLC2029275Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +16 moreCorona, CANot verifiedOct 21, 2026
Sterigenics US LLC2011171Contract sterilizerCardiovascular; General and plastic surgery; General hospital +13 moreLos Angeles, CANot verifiedOct 21, 2026

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