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Device Explorer · FDA GUDID · GMDN 44746

Inhalation therapy saline solution, isotonic

A sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the re

US‑registered devices80in commercial distribution
Companies11labelers on GUDID
Single‑use95%of device records
Sterile39%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Teleflex Incorporated4354%
Medline Industries, Inc.1215%
Ritedose Pharmaceuticals, Llc79%
Airlife79%
Amsino International, Inc.34%
Lifestar Pharma Llc22%
Nephron Pharmaceuticals22%
Chartwell Rx, Llc11%

Top labelers

CompanyDevicesShare
Teleflex Incorporated4354%
Medline Industries, Inc.1215%
Ritedose Pharmaceuticals, Llc79%
Airlife79%
Amsino International, Inc.34%
Lifestar Pharma Llc22%
Nephron Pharmaceuticals22%
Chartwell Rx, Llc11%
Bridge To Life Ltd.11%
Westmed, Inc.11%
Avanos Medical, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HUDSON RCISodium Chloride for Inhalation Solution 0.9%EasiSlushPulmonary Hygiene KitSodium Chloride Inhalation Solution, USP, 0.45% Sodium Chloride Inhalation Solution, USP, 0.45% Sodium Chloride Inhalation Solution, USP, 0.9% 1Sodium Chloride Inhalation Solution, USP, 0.9% 5Sodium Chloride Inhalation Solution, USP, 0.9% 3Sodium Chloride Inhalation Solution, USP, 0.9% 3Sodium Chloride Inhalation Solution, USP, 0.9%-5Sodium Chloride Inhalation Solution, USP, 0.9%-3Sodium Chloride Inhalation Solution, USP 0.9%AMSure® Sodium Chloride Inhalation Solution, USPAMSure® Sodium Chloride Inhalation Solution, USPAMSure® Sodium Chloride Inhalation Solution, USP

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

FDA product codes

CodeNameDevices
OGGHumidifier nebulizer kit21
CAFNebulizer (Direct Patient Interface)19
CAFNEBULIZER (DIRECT PATIENT INTERFACE)18
CAFNebulizer (direct patient interface)17
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)2
OGGHumidifier Nebulizer Kit2

GMDN & GCC registration

  • GMDN code 44746 · non‑implantable
  • Single‑use 95% · sterile 39% · Rx‑only 95% · 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

No structured size data on the register.

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

How many inhalation therapy saline solution, isotonic products are registered in the US?

80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inhalation therapy saline solution, isotonic", from 11 companies. The largest labeler is Teleflex Incorporated with 54% of records.

Which FDA product codes apply?

OGG (Humidifier nebulizer kit), CAF (Nebulizer (Direct Patient Interface)), CAF (NEBULIZER (DIRECT PATIENT INTERFACE)), CAF (Nebulizer (direct patient interface))

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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