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Device Explorer · FDA GUDID · GMDN 46232

Anaesthesia face mask, single-use

A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a

US‑registered devices917in commercial distribution
Companies42labelers on GUDID
Single‑use97%of device records
Sterile4%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Teleflex Incorporated859%
Parker-Hannifin Corporation738%
Ventlab, Llc708%
Accutron, Inc.677%
Airlife516%
Xiamen Compower Medical Tech. Co., Ltd495%
Medline Industries, Inc.495%
Flexicare Medical Limited435%

Top labelers

CompanyDevicesShare
Teleflex Incorporated859%
Parker-Hannifin Corporation738%
Ventlab, Llc708%
Accutron, Inc.677%
Airlife516%
Xiamen Compower Medical Tech. Co., Ltd495%
Medline Industries, Inc.495%
Flexicare Medical Limited435%
Besmed Health Business Corp.404%
Drägerwerk Ag & Co. Kgaa404%
Ambu A/S384%
Intersurgical Incorporated354%

Company = labeler of record on GUDID. 42 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

O-TwoDisposable Anesthetic MaskscompowerCompowerTypenexEVER READY FIRST AIDMCRNAAnaesthetic Mask, Size 000#Anaesthetic Mask, Size 00#Anaesthetic Mask, Size 6#Anaesthetic Mask, Size 5#Anaesthetic Mask, Size 4#Anaesthetic Mask, Size 3#Anaesthetic Mask, Size 2#Anaesthetic Mask, Size 1#

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

FDA product codes

CodeNameDevices
BSJMask, Gas, Anesthetic419
BSJMASK, GAS, ANESTHETIC324
KHAMask, Scavenging173
CAICircuit, breathing (w connector, adaptor, y piece)29
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)22
BYGMASK, OXYGEN12

GMDN & GCC registration

  • GMDN code 46232 · non‑implantable
  • Single‑use 97% · sterile 4% · Rx‑only 85% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 30Length (Millimeter) · 30Height (Millimeter) · 12Total Volume (Milliliter) · 6

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

How many anaesthesia face mask, single-use products are registered in the US?

917 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Anaesthesia face mask, single-use", from 42 companies. The largest labeler is Teleflex Incorporated with 9% of records.

Which FDA product codes apply?

BSJ (Mask, Gas, Anesthetic), BSJ (MASK, GAS, ANESTHETIC), KHA (Mask, Scavenging), CAI (Circuit, breathing (w connector, adaptor, y piece))

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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