FDA Registration
Active
🇺🇸 United States
Ameritus ENFit enteral feeding tube(vr)
Reg #: 2080225
·
FEI: 2080225
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- KENTEC MEDICAL, INC.
- Registration Number
- 2080225
- FEI Number
- 2080225
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17871 FITCH
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180236
Owner / Operator
- Firm Name
- KENTEC MEDICAL, INC.
- Operator Number
- 2080225
- Address
- 17871 FITCH, --
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2020-07-28 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2020-07-28 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2020-07-28 |
Proprietary Names
Ameritus ENFit enteral feeding tube(vr)
Establishment Types
Complaint File Establishment per 21 CFR 820.198