Identity
- Trade Name
- NeuroSENSE FDA UDI
- Generic Name
- Anaesthesia depth monitor FDA UDI
- Model / Reference
- NS-901 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B746NS90101 FDA UDI
- FDA Product Code
- OLW FDA UDI
- GMDN Term
- Anaesthesia depth monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Anaesthesia depth monitor
NeuroSENSE by Neurowave Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anaesthesia depth monitor.
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- BIS — Covidien LP · Class II
- BIS — Covidien LP · Class II
- BIS — Covidien LP · Class II
- BIS — Covidien LP · Class II
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
- Neurowave Systems, Inc.
Sources (1)
- FDA UDI b63c7576-63c1-44af-b655-5a9594a58f3b 32 fields · synced May 30, 2026