Identity
- Trade Name
- INOmax FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797 FDA UDI
- Model / Reference
- 81097 FDA UDI
- Description
- ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055280971 FDA UDI
- FDA Product Code
- BZO FDA UDI
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5975 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
Category: Nitric oxide delivery unit, system-based
INOmax by Mallinckrodt Manufacturing, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitric oxide delivery unit, system-based.
- AeroNOx Nitric Oxide Delivery Device — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- GENOSYL® — VERO BIOTECH INC. · Class I
- Luer Elbow 7.6mm Port Kit — Beyond Air, Inc. · Class III
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mallinckrodt Manufacturing, LLC
Sources (1)
- FDA UDI 729517bc-8493-4343-9802-0cab49f21165 35 fields · synced May 30, 2026