Identity
- Trade Name
- INOblender FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- INOblender FDA UDI
- Model / Reference
- 10004 FDA UDI
- Description
- INOblender FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867538000120 FDA UDI
- FDA Product Code
- MRO FDA UDI
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5165 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
No
FDA UDI
Category: Nitric oxide delivery unit, system-based
INOblender by Mallinckrodt Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitric oxide delivery unit, system-based.
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- NOxBOXi — NOXBOX LTD · Class II
- NOxBOXi — NOXBOX LTD · Class II
- GENOSYL® — VERO BIOTECH INC. · Class II
- GENOSYL® — VERO BIOTECH INC. · Class II
- GENOSYL® — VERO BIOTECH INC. · Class I
Cleared under the same submission
K052663 also covers:
K122689 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
- Mallinckrodt Manufacturing, LLC
Sources (1)
- FDA UDI 682c6202-bcf8-4ce0-b1ff-050d3e37fa57 36 fields · synced May 31, 2026