Identity
- Trade Name
- Prefense FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Prefense - Early Detection and Notification System (PC) FDA UDI
- Model / Reference
- EDNS-9001 FDA UDI
- Description
- Prefense - Early Detection and Notification System (PC) FDA UDI
Identifiers
- Catalog Number
- EDNS-9001 FDA UDI
- Primary DI / UDI-DI
- 00851725007023 FDA UDI
- FDA Product Code
- MHX FDA UDIDRG FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2910 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
No
FDA UDI
Category: Centralized patient monitor
Prefense 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 d210c6e7-1217-43a1-b5ab-3141f112eb5d 36 fields · synced May 30, 2026