INOmax (UDI 81092)
Manufactured by Mallinckrodt Manufacturing LLC
Device Regulatory Overview
The INOmax (Model/Catalog Number: 81092) is a medical device manufactured by Mallinckrodt Manufacturing LLC. This product is indexed under FDA Product Code / Category Classification BZO within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 81092
- Product Code / EMDN
- BZO
- Device Name
- Line, 10ft patient gas sample BCG, CE
- Database Sync Date
- 2026-08-09 09:09:58
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of INOmax?
The registered manufacturer of record for INOmax is Mallinckrodt Manufacturing LLC.
What is the Primary UDI-DI identifier for INOmax?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 81092.
What classification code is assigned to this device?
This device is registered under product classification code BZO.
Similar Classification Devices (BZO)
Other Devices by Mallinckrodt Manufacturing LLC
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