FDA Registration
Active
🇺🇸 United States
ivNow Modular Fluid Warmer
Reg #: 2131400
·
FEI: 1000116410
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENTHERMICS MEDICAL SYSTEMS, INC.
- Registration Number
- 2131400
- FEI Number
- 1000116410
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- WEST 164 NORTH 9221 WATER ST.
- City
- MENOMONEE FALLS
- State
- WI
- ZIP
- 53051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091336
Owner / Operator
- Firm Name
- ENTHERMICS MEDICAL SYSTEMS, INC.
- Operator Number
- 9027259
- Address
- WEST 164 NORTH 9221 WATER ST., --
- City
- Menomonee Falls
- State
- WI
- Postal Code
- 53051
- Country
- US
- Correspondent
- Nicole - Polley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2010-05-12 |
Proprietary Names
ivNow Modular Fluid Warmer
MEDIVNOW
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)