FDA Registration
Active
🇺🇸 United States
PeritX 2L Drainage Starter Tote
Reg #: 1423507
·
FEI: 3008002452
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CAREFUSION 2200, INC.
- Registration Number
- 1423507
- FEI Number
- 3008002452
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 75 North Fairway Drive
- City
- Vernon Hills
- State
- IL
- ZIP
- 60061
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241946
Owner / Operator
- Firm Name
- CAREFUSION
- Operator Number
- 10030506
- Address
- 75 N Fairway Dr
- City
- Vernon Hills
- State
- IL
- Postal Code
- 60061
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2025-01-09 |
Proprietary Names
PeritX 2L Drainage Starter Tote
PeritX Peritoneal Catheter System
PeritX 2L Drainage Kit
PeritX 2L Drainage Starter Pack
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility