Identity
- Trade Name
- Nihon Kohden FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- The exhalation port is intended to be part of a single limb breathing circuit from the NKV-330 ventilator. The exhalation port provides a fixed leak and connection for pressure measurement. FDA UDI
- Model / Reference
- EXH3301P FDA UDI
- Description
- The exhalation port is intended to be part of a single limb breathing circuit from the NKV-330 ventilator. The exhalation port provides a fixed leak and connection for pressure measurement. FDA UDI
Identifiers
- Catalog Number
- EXH3301P FDA UDI
- Primary DI / UDI-DI
- 00843685100135 FDA UDI
- 510(k) Number
- K213521 FDA UDI
- FDA Product Code
- MNT FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Ventilator breathing circuit, single-use
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
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 3fb63df9-bc72-429e-8f2b-14feec05114d 37 fields · synced Jun 8, 2026