FDA Registration
Inactive
🇺🇸 United States
SIMERGENT, LLC
·
Expires 2026
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIMERGENT, LLC
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11 NE 11th St, Suite 229
- City
- Oklahoma City
- State
- OK
- ZIP
- 73104
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250523
Owner / Operator
- Firm Name
- Simergent, LLC
- Operator Number
- 10096032
- Address
- 11 NE 11th St, Suite 229
- City
- Oklahoma City
- State
- OK
- Postal Code
- 73104
- Country
- US
- Correspondent
- Steve J Lindo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2026-06-10 |
Proprietary Names
Archimedes Standard Automated Peritoneal Dialysis Cycler
Archimedes Standard Disposable Tubing Set
Archimedes Pro Plus Disposable Tubing Set
Archimedes Pro Automated Peritoneal Dialysis Cycler
Archimedes Pro Disposable Tubing Set
Establishment Types
Manufacture Medical Device