Identity
- Trade Name
- NPS2 Nihon Kohden BSM 8800 FDA UDI
- Generic Name
- Intracranial/compartmental-pressure monitor calibrator/cable FDA UDI
- Model / Reference
- 091676-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057834024739 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracranial/compartmental-pressure monitor calibrator/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Commercial Distribution
- Not 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
NPS2 Nihon Kohden BSM 8800 by Raumedic Ag — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Raumedic Ag
Sources (1)
- FDA UDI 59d31355-86d0-4354-890b-96f2a061ae91 35 fields · synced May 31, 2026