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Device Explorer · FDA GUDID · GMDN 44706

Inhalation therapy sterile water

A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxyg

US‑registered devices126in commercial distribution
Companies7labelers on GUDID
Single‑use97%of device records
Sterile48%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Teleflex Incorporated7560%
Medline Industries, Inc.2520%
Airlife1411%
Amsino International, Inc.54%
Mckesson Medical-Surgical Inc.43%
Ritedose Pharmaceuticals, Llc22%
Sunmed, Llc11%

Top labelers

CompanyDevicesShare
Teleflex Incorporated7560%
Medline Industries, Inc.2520%
Airlife1411%
Amsino International, Inc.54%
Mckesson Medical-Surgical Inc.43%
Ritedose Pharmaceuticals, Llc22%
Sunmed, Llc11%

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

Brand names on the register (sample)

HUDSON RCISterile Water for Inhalation, USP, 5 mL UDVSterile Water for Inhalation, USP, 3 mL UDVAMSure® Sterile Water for Inhalation, USP 1000mLAMSure® Sterile Water for Inhalation, USP PrefilAMSure® Sterile Water for Inhalation, USP PrefilAMSure® Sterile Water for Inhalation, USP 5mLAMSure® Sterile Water for Inhalation, USP 3mLMcKessonHudson RCIAirLifeAirlifeAirLife™MedlineAirlife™ Sterile water for Inhalation, USP 2000

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 kit41
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)40
CAFNebulizer (Direct Patient Interface)17
CAFNebulizer (direct patient interface)15
CAFNEBULIZER (DIRECT PATIENT INTERFACE)10
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)6

GMDN & GCC registration

  • GMDN code 44706 · non‑implantable
  • Single‑use 97% · sterile 48% · Rx‑only 99% · 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

Total Volume (Milliliter) · 3

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

How many inhalation therapy sterile water products are registered in the US?

126 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inhalation therapy sterile water", from 7 companies. The largest labeler is Teleflex Incorporated with 60% of records.

Which FDA product codes apply?

OGG (Humidifier nebulizer kit), BTT (HUMIDIFIER, RESPIRATORY GAS, (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.

How do I get quotes?

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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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