Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) contract manufacturers
8 US facilities list FDA product code KDI as a contract manufacturer (1) or contract sterilizer (7).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Product code
- KDI (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 876.5860
- Classification panel
- Gastroenterology and urology
- FDA flags
- life-sustaining or life-supporting
Where they are
California 2 · Minnesota 2 · Texas 2 · South Carolina 1 · Utah 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Orthopedic +13 more | Spartanburg, SC | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | 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 |
| 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 US LLC | 1649518 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +13 more | Fort Worth, TX | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| Synergy Health AST, LLC | 3012102437 | Contract sterilizer | Cardiovascular; General and plastic surgery; Orthopedic +6 more | Petaluma, CA | Not verified | Oct 21, 2026 |
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