FDA Registration
Active
🇺🇸 United States
7CN80H 8MM TRACH CFD DIC
Reg #: 1721686
·
FEI: 1721686
·
Expires 2025
Products
1
Proprietary Names
71
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1721686
- FEI Number
- 1721686
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2400 Airport Rd
- City
- Santa Teresa
- State
- NM
- ZIP
- 88008
- Country
- US
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2018-09-12 |
Proprietary Names
7CN80H 8MM TRACH CFD DIC
3NEF 3 MM ID,NEONATAL,CUFFLESS, PHTHALATE FREE
4.5PCF 4.5 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
6.5PELF 6.5 MM ID,PEDIATRIC LONG,CUFFLESS,PHTHALATE FREE
5.5PEF 5.5 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
8UN85A 8.5MM Trach CFLS With DIC
5.5PLCF 5.5 MM ID, PEDIATRIC, LONG, CUFFED, PHTHALATE FREE
9UN90H 9MM TRACH CFLS WITH DIC
5UN70A 7MM Trach CFLS With DIC
Shiley Cuffless Neonatal/Pediatric Tracheostomy Tubes
4CN65H 6.5MM TRACH CFD DIC
4PEF 4 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
2.5PCF 2.5 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
2.5NEF 2.5 MM ID,NEONATAL,CUFFLESS, PHTHALATE FREE
4NCF 4 MM ID, NEONATAL,CUFFED, PHTHALATE FREE
5CN70A 7MM Trach CFD DIC
7CN80A 8MM Trach CFD DIC
8UN85H 8.5MM TRACH CFLS WITH DIC
5PELF 5 MM ID,PEDIATRIC LONG,CUFFLESS,PHTHALATE FREE
9CN90H 9MM TRACH CFD DIC
3.5PEF-P 3.5MM ID, PEDIATRIC, CUFFLESS, PHTHALATE FREE, 4-PACK
5PEF-P 5MM ID, PEDIATRIC, CUFFLESS, PHTHALATE FREE, 4-PACK
6PLCF 6 MM ID, PEDIATRIC, LONG, CUFFED, PHTHALATE FREE
2.5PEF 2.5 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
10CN10A 10MM Trach CFD DIC
5.5PEF-P 5.5MM ID, PEDIATRIC, CUFFLESS, PHTHALATE FREE, 4-PACK
7UN80H 8MM TRACH CFLS WITH DIC
4NEF 4 MM ID,NEONATAL,CUFFLESS, PHTHALATE FREE
5.5PCF 5.5 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
5PLCF 5 MM ID, PEDIATRIC, LONG, CUFFED, PHTHALATE FREE
6.5PLCF 6.5 MM ID, PEDIATRIC, LONG, CUFFED, PHTHALATE FREE
4.5NCF 4.5 MM ID, NEONATAL,CUFFED, PHTHALATE FREE
4PEF-P 4MM ID, PEDIATRIC, CUFFLESS, PHTHALATE FREE, 4-PACK
3.5NEF 3.5 MM ID,NEONATAL,CUFFLESS, PHTHALATE FREE
3.5PEF 3.5 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
8CN85H 8.5MM TRACH CFD DIC
5CN70H 7MM TRACH CFD DIC
4.5PEF-P 4.5MM ID, PEDIATRIC, CUFFLESS, PHTHALATE FREE, 4-PACK
4.5NEF 4.5 MM ID,NEONATAL,CUFFLESS, PHTHALATE FREE
6UN75A 7.5MM Trach CFLS With DIC
9UN90A 9MM Trach CFLS With DIC
4UN65A 6.5MM Trach CFLS With DIC
9CN90A 9MM Trach CFD DIC
6CN75A 7.5MM Trach CFD DIC
4UN65H 6.5MM TRACH CFLS WITH DIC
7UN80A 8MM Trach CFLS With DIC
10CN10H 10MM TRACH CFD DIC
5PEF 5 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
10UN10H 10MM TRACH CFLS WITH DIC
3.5NEF-P 3.5MM ID, NEONATALL, CUFFLESS, PHTHALATE FREE, 4-PACK
6UN75H 7.5MM TRACH CFLS WITH DIC
3NCF 3 MM ID, NEONATAL,CUFFED, PHTHALATE FREE
2.5NCF 2.5 MM ID, NEONATAL,CUFFED, PHTHALATE FREE
5PCF 5 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
3PCF 3 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
3.5NCF 3.5 MM ID, NEONATAL,CUFFED, PHTHALATE FREE
5.5PELF 5.5 MM ID,PEDIATRIC LONG,CUFFLESS,PHTHALATE FREE
3PEF 3 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
3.5PCF 3.5 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
3PEF-P 3MM ID, PEDIATRIC, CUFFLESS, PHTHALATE FREE, 4-PACK
3NEF-P 3MM ID, NOENATAL, CUFFLESS, PHTHALATE FREE, 4-PACK
4NEF-P 4MM ID, NEONATAL, CUFFLESS, PHTHALATE FREE, 4-PACK
5UN70H 7MM TRACH CFLS WITH DIC
6CN75H 7.5MM TRACH CFD DIC
4.5NEF-P 4.5MM ID, NEONATAL, CUFFLESS, PHTHALATE FREE, 4-PACK
4CN65A 6.5MM Trach CFD DIC
8CN85A 8.5MM Trach CFD DIC
10UN10A 10MM Trach CFLS With DIC
6PELF 6 MM ID,PEDIATRIC LONG,CUFFLESS,PHTHALATE FREE
4PCF 4 MM ID, PEDIATRIC,CUFFED, PHTHALATE FREE
4.5PEF 4.5 MM ID,PEDIATRIC,CUFFLESS,PHTHALATE FREE
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)