Reservoir, Blood, Cardiopulmonary Bypass (DTN) contract manufacturers
9 US facilities list FDA product code DTN as a contract manufacturer (2) or contract sterilizer (7).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Reservoir, Blood, Cardiopulmonary Bypass
- Product code
- DTN (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 870.4400
- Classification panel
- Cardiovascular
Where they are
California 2 · Colorado 1 · Minnesota 1 · Missouri 1 · North Carolina 1 · New York 1 · South Carolina 1 · Texas 1
All 9 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 |
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Orthopedic +13 more | Spartanburg, SC | Not verified | Oct 21, 2026 |
| KLUGE DESIGN INC. | 3003661577 | Contract manufacturer | Gastroenterology and urology; Cardiovascular; General and plastic surgery +1 more | Rogers, MN | 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 |
| ROBLING MEDICAL, LLC | 3007829657 | Contract manufacturer | General and plastic surgery; General hospital; Gastroenterology and urology +6 more | Youngsville, NC | 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 | 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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