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Device Explorer · FDA GUDID · GMDN 31309

Nebulizing system delivery set, single-use

A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is

US‑registered devices365in commercial distribution
Companies39labelers on GUDID
Single‑use92%of device records
Sterile1%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Medline Industries, Inc.6317%
Westmed, Inc.5716%
Sunmed, Llc4312%
Amsino International, Inc.205%
Medi/Nuclear Corporation, Inc.195%
Intersurgical Incorporated175%
Bound Tree Medical, Llc144%
Galemed Corporation113%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.6317%
Westmed, Inc.5716%
Sunmed, Llc4312%
Amsino International, Inc.205%
Medi/Nuclear Corporation, Inc.195%
Intersurgical Incorporated175%
Bound Tree Medical, Llc144%
Galemed Corporation113%
Medsource International Llc103%
A-M Systems, Llc92%
Tri-Anim Health Services, Inc.82%
Omron Healthcare, Inc.82%

Company = labeler of record on GUDID. 39 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

O-TwoNebulizer KitN/ACIRRUS2 NEBULISER 18M WITH TUBE, 1.8MCIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLCIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE CIRRUS™2 NEBULISER MOUTHPIECE KIT AND TUBE WITH CIRRUS2 NEBULISER MOUTHPIECE KIT WITH TUBE, 2.1MNEBULISER ANGLED MOUTHPIECE 22M-22MCIRRUS2 NEBULISER, SINGLE PATIENT USECIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE CIRRUS2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOCIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLCIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE CIRRUS 2 NEBULISERCIRRUS2 NEBULISER MOUTHPIECE KIT WITH TUBE, 2.1M

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

FDA product codes

CodeNameDevices
CAFNebulizer (Direct Patient Interface)259
CAFNebulizer (direct patient interface)36
CAFNEBULIZER (DIRECT PATIENT INTERFACE)35
BTICompressor, air, portable27
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)21
BYGMask, Oxygen15

GMDN & GCC registration

  • GMDN code 31309 · non‑implantable
  • Single‑use 92% · sterile 1% · Rx‑only 90% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 5

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

How many nebulizing system delivery set, single-use products are registered in the US?

365 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nebulizing system delivery set, single-use", from 39 companies. The largest labeler is Medline Industries, Inc. with 17% of records.

Which FDA product codes apply?

CAF (Nebulizer (Direct Patient Interface)), CAF (Nebulizer (direct patient interface)), CAF (NEBULIZER (DIRECT PATIENT INTERFACE)), BTI (Compressor, air, portable)

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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