FDA Registration
Active
🇺🇸 United States
Fresenius Sterile Stay Safe Cap
Reg #: 1225714
·
FEI: 3001451489
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Registration Number
- 1225714
- FEI Number
- 3001451489
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 920 WINTER STREET
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083542
Owner / Operator
- Firm Name
- Fresenius Medical Care North America
- Operator Number
- 9030510
- Address
- 920 WINTER STREET, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
- Correspondent
- Rachel Lloyd
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | Class 2 | Gastroenterology, Urology | No | 2008-12-30 |
Proprietary Names
Fresenius Sterile Stay Safe Cap
Establishment Types
Complaint File Establishment per 21 CFR 820.198