Identity
- Trade Name
- NetKonnect FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- NetKonnect Option BS-984P (RNS Option) FDA UDI
- Model / Reference
- BS-984P FDA UDI
- Description
- NetKonnect Option BS-984P (RNS Option) FDA UDI
Identifiers
- Catalog Number
- BS-984P FDA UDI
- Primary DI / UDI-DI
- 00851725007085 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Centralized patient monitor
NetKonnect by Nihon Kohden Digital Health Solutions LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nihon Kohden Digital Health Solutions LLC
Sources (1)
- FDA UDI 42c8ba3e-0fa3-4aa4-a4c3-9fa214b11ccd 36 fields · synced May 30, 2026