Heat-Exchanger, Cardiopulmonary Bypass (DTR) contract manufacturers
7 US facilities list FDA product code DTR as a contract manufacturer (0) or contract sterilizer (7).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Heat-Exchanger, Cardiopulmonary Bypass
- Product code
- DTR (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 870.4240
- Classification panel
- Cardiovascular
- FDA flags
- life-sustaining or life-supporting
Where they are
California 2 · Colorado 1 · Missouri 1 · New York 1 · Texas 1 · Utah 1
All 7 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Cardiovascular +14 more | El Paso, TX | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 1928237 | Contract sterilizer | General and plastic surgery; Cardiovascular; General hospital +14 more | Jackson, MO | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +14 more | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721676 | Contract sterilizer | Cardiovascular; Orthopedic; General and plastic surgery +12 more | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | General and plastic surgery; Orthopedic; Cardiovascular +16 more | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 2011171 | Contract sterilizer | Cardiovascular; General and plastic surgery; General hospital +13 more | Los Angeles, CA | Not verified | Oct 21, 2026 |
| Terumo BCT STERILIZATION SERVICES, Inc. | 1724474 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +6 more | Lakewood, CO | Not verified | Oct 21, 2026 |
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