Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012796317

FEI Number

3012796317

Entity Name

NOXBOX LIMITED

City/State/Country

Sittingbourne Kent, GB

Establishment Address

1 Eurolink Gateway, Castle Road, Sittingbourne Kent ME10 3AG, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NOxBOX Limited (Owner Number: 10058545)

Owner / Operator Contact Address

1 Eurolink Gateway, Castle Road, Sittingbourne, GB-KEN ME10 3AG, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233251

PMA Number

N/A

All Registered Proprietary Names

NOxBOXi Nitric Oxide Delivery and Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2026-01-15
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2026-01-15
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2026-01-15
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2026-01-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-01-15

Official Correspondent

Dave Loflin

US Agent Details

Dave Loflin Business: Linde Gas & Equipment Inc Email: dave.loflin@linde.com Phone: (412) 8743315

Related Public Records

Same Entity

NOxBOX Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Similar Registrations

Registration Number	Establishment Name	Location
3004531588	Mallinckrodt Manufacturing LLC	MADISON, WI, US
2518435	Airgas Therapeutics LLC	PLUMSTEADVILLE, PA, US
3014527933	MALLINCKRODT HOSPITAL PRODUCTS INC.	Bridgewater, NJ, US
1625392	INTERNATIONAL BIOMEDICAL, LTD.	AUSTIN, TX, US
3019771924	INOSYSTEMS	ANTONY Hauts-de-Seine, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012796317. Last updated year: 2026. Please use registration number 3012796317 when referencing this establishment in official correspondence.