NOxBOXi

FDA UDI

Class II (US FDA UDI)

by Noxbox Ltd

Identity

Trade Name: NOxBOXi FDA UDI
Generic Name: Nitric oxide delivery unit, system-based FDA UDI
Device Name: Single use 22mm one-way valve for use with Sensor Medics 3100A/B HFO ventilators FDA UDI
Model / Reference: FXS555 FDA UDI
Description: Single use 22mm one-way valve for use with Sensor Medics 3100A/B HFO ventilators FDA UDI

Identifiers

Catalog Number: NXBFXS555 FDA UDI
Primary DI / UDI-DI: 15060541640112 FDA UDI
510(k) Number: K171696 FDA UDI
FDA Product Code: CCL FDA UDI
MRQ FDA UDI
MRP FDA UDI
MRO FDA UDI
MRN FDA UDI
GMDN Term: Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1720 FDA UDI
868.2385 FDA UDI
868.2380 FDA UDI
868.5165 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nitric oxide delivery unit, system-based

NOxBOXi by Noxbox Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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INOmax — Mallinckrodt Manufacturing, LLC · Class II
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Cleared under the same submission

K171696 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: Noxbox Ltd

Sources (1)

FDA UDI 69c17b9f-7c84-4a92-80ee-db97d7c7c6de 37 fields · synced Jun 6, 2026