Identity
- Trade Name
- INOcal FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- INOcal 45 PPM NO Calibration Gas FDA UDI
- Model / Reference
- BOM-COM-0159 FDA UDI
- Description
- INOcal 45 PPM NO Calibration Gas FDA UDI
Identifiers
- Catalog Number
- BOM-COM-0159 FDA UDI
- Primary DI / UDI-DI
- 00810055280025 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6400 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitric oxide delivery unit, system-based
INOcal by Mallinckrodt Manufacturing, LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Mallinckrodt Manufacturing, LLC
Sources (1)
- FDA UDI 6d5cb41c-ebe7-4fa2-8dfb-2b8957994ec8 36 fields · synced May 30, 2026