Identity
- Trade Name
- NXT FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- NXT Evo FDA UDI
- Model / Reference
- NXT2400 FDA UDI
- Description
- NXT Evo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825011648 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urodynamic measurement system
The NXT device is a high-quality, advanced urodynamic measurement system designed to help diagnose and treat urinary disorders. With its cutting-edge technology and robust features, it is an ideal solution for healthcare professionals looking to improve patient outcomes.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
Sources (1)
- FDA UDI 285f03c9-acc0-4c90-8caa-a2b320775f88 33 fields · synced Jul 25, 2026