Identity
- Trade Name
- Nihon Kohden FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator configurations. The Graphical User Interface may be provided to users as a replacement or as a second Graphical User Interface. FDA UDI
- Model / Reference
- DSP5500A FDA UDI
- Description
- The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator configurations. The Graphical User Interface may be provided to users as a replacement or as a second Graphical User Interface. FDA UDI
Identifiers
- Catalog Number
- DSP5500A FDA UDI
- Primary DI / UDI-DI
- 00843685100036 FDA UDI
- 510(k) Number
- K181695 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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: Neonatal/adult intensive-care ventilator
Nihon Kohden by Nihon Kohden OrangeMed, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181695 also covers:
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 OrangeMed, LLC
Sources (1)
- FDA UDI fb5e412b-3640-4dc5-988f-8d5211518235 37 fields · synced Jun 8, 2026