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Device Explorer · FDA GUDID · GMDN 37266

Nitric oxide delivery unit, system-based

A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients

US‑registered devices148in commercial distribution
Companies7labelers on GUDID
Single‑use70%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Mallinckrodt Manufacturing Llc6745%
Vero Biotech Inc.3020%
Noxbox Ltd1510%
Beyond Air, Inc.149%
International Biomedical, Ltd.117%
Linde Gas & Equipment Inc.107%
Airgas Therapeutics, Llc11%

Top labelers

CompanyDevicesShare
Mallinckrodt Manufacturing Llc6745%
Vero Biotech Inc.3020%
Noxbox Ltd1510%
Beyond Air, Inc.149%
International Biomedical, Ltd.117%
Linde Gas & Equipment Inc.107%
Airgas Therapeutics, Llc11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NOxBOXiUlspira TSAeroNOx Nitric Oxide Delivery DeviceINOblender MRIINOblenderINOmax DSIR Plus MRIINOmax DSIR PlusAeroNOx 2.0 Nitric Oxide Delivery DeviceNOxBOXi NOXKIT 3-HFJVNOxBOXi NOXKIT 3-22NOxBOXi NOxFLOWNOxBOXi NOXKIT EMERNOxBOXi NOXKIT HFJVNOxBOXi NOXKIT 2-15NOxBOXi NOXKIT 2-22NOxBOXi NOXKIT 2-12

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MRNApparatus, Nitric Oxide Delivery67
BZOSet, Tubing And Support, Ventilator (W Harness)37
MRPAnalyzer, Nitric Oxide30
MROApparatus, Nitric Oxide, Backup Delivery22
MRQAnalyzer, Nitrogen Dioxide19
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase16

GMDN & GCC registration

  • GMDN code 37266 · non‑implantable
  • Single‑use 70% · sterile 0% · Rx‑only 93% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Centimeter) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many nitric oxide delivery unit, system-based products are registered in the US?

148 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nitric oxide delivery unit, system-based", from 7 companies. The largest labeler is Mallinckrodt Manufacturing Llc with 45% of records.

Which FDA product codes apply?

MRN (Apparatus, Nitric Oxide Delivery), BZO (Set, Tubing And Support, Ventilator (W Harness)), MRP (Analyzer, Nitric Oxide), MRO (Apparatus, Nitric Oxide, Backup Delivery)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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