Identity
- Trade Name
- NOxBOXi NOxFLOW FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- NXBNOXFLOW-2 FDA UDI
- Primary DI / UDI-DI
- 00850046301148 FDA UDI
- FDA Product Code
- MRP FDA UDI
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2380 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitric oxide delivery unit, system-based
NOxBOXi NOxFLOW by Linde Gas & Equipment Inc. — 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
- Linde Gas & Equipment Inc.
Sources (1)
- FDA UDI f498f448-51b9-48bc-94e5-3dcef484667a 34 fields · synced Sep 18, 2026