FDA Registration
Active
🇺🇸 United States
Multi Drip® PMD40-12, 4ml/hr 12 cm drip zone
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2029275
- FEI Number
- 1000306431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 344 Bonnie Cir
- City
- Corona
- State
- CA
- ZIP
- 92878
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042246
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 |
|---|---|---|---|---|---|
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2012-10-30 |
Proprietary Names
Multi Drip® PMD40-12, 4ml/hr 12 cm drip zone
Multi Drip® PMD40-6, 4ml/hr 6 cm drip zone
Micro Multi Drip¿ MMD20-6, 2 ml/hr 6 cm zone
Multi Drip® PMD20-24, 2ml/hr 24 cm drip zone
Multi Drip® PMD40-24, 4ml/hr 24 cm drip zone
Multi Drip® PMD80-12, 8ml/hr 12 cm drip zone
Multi Drip® PMD20-6, 2ml/hr 6 cm drip zone
Micro Multi Drip¿ MMD20-8, 2 ml/hr 8 cm zone
Micro Multi Drip¿ MMD10-8, 1 ml/hr 8 cm zone
Micro Multi Drip¿ MMD10-6, 1 ml/hr 6 cm zone
Multi Drip® PMD20-12, 2ml/hr 12 cm drip zone
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)