MedtechSourcebook

Tubing, Pump, Cardiopulmonary Bypass (DWE) contract manufacturers

6 US facilities list FDA product code DWE as a contract manufacturer (1) or contract sterilizer (5).

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

FDA device name
Tubing, Pump, Cardiopulmonary Bypass
Product code
DWE (FDA product classification database)
Device class
Class II
Regulation
21 CFR 870.4390
Classification panel
Cardiovascular

Where they are

California 2 · Colorado 1 · Massachusetts 1 · Missouri 1 · Utah 1

All 6 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
MIDWEST STERILIZATION CORP.1928237Contract sterilizerGeneral and plastic surgery; Cardiovascular; General hospital +14 moreJackson, MONot verifiedOct 21, 2026
Primo Medical Group, INC1222928Contract manufacturerOrthopedic; General and plastic surgery; Gastroenterology and urology +6 moreStoughton, MANot verifiedOct 21, 2026
Sterigenics U.S., LLC1721676Contract sterilizerCardiovascular; Orthopedic; General and plastic surgery +12 moreSalt Lake City, UTNot 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
Terumo BCT STERILIZATION SERVICES, Inc.1724474Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +6 moreLakewood, CONot verifiedOct 21, 2026

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