Consulting Wallah › Device Explorer › Gloves & PPE › Laryngeal mask airway, single-use
Device Explorer · FDA GUDID · GMDN 45036

Laryngeal mask airway, single-use

A curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted

US‑registered devices951in commercial distribution
Companies26labelers on GUDID
Single‑use95%of device records
Sterile87%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Teleflex Incorporated49252%
Intersurgical Incorporated616%
Bound Tree Medical, Llc556%
Flexicare Medical Limited495%
Sourcemark, Llc.495%
Ambu A/S465%
Airlife354%
Jiangxi Yiles Medical Co., Ltd243%

Top labelers

CompanyDevicesShare
Teleflex Incorporated49252%
Intersurgical Incorporated616%
Bound Tree Medical, Llc556%
Flexicare Medical Limited495%
Sourcemark, Llc.495%
Ambu A/S465%
Airlife354%
Jiangxi Yiles Medical Co., Ltd243%
Medline Industries, Inc.243%
Tianjin Medis Medical Device Co.,Ltd.162%
Jiangxi Glance Medical Equipment Co., Ltd.152%
Henan Tuoren Medical Device Co.,Ltd.141%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAUltra TCUltra Clear TCUltra ClearInsighterLaryngeal Mask Airway Silicone Size 6.0Laryngeal Mask Airway, Silicone Wire Reinforced,Laryngeal Mask Airway, Silicone Wire Reinforced,Laryngeal Mask Airway, Silicone Wire Reinforced,Laryngeal Mask Airway, Silicone Wire Reinforced,Laryngeal Mask Airway, Silicone Wire Reinforced,Laryngeal Mask Airway Silicone Wire Reinforced SLaryngeal Mask Airway Silicone Wire Reinforced Laryngeal Mask Airway Silicone Size 5.0Laryngeal Mask Airway Silicone Size 4.0Laryngeal Mask Airway Silicone Size 3.0

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

FDA product codes

CodeNameDevices
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY626
CAEAirway, Oropharyngeal, Anesthesiology318
BTRTube, tracheal (w/wo connector)15
FMFSyringe, piston12
OFOAirway Suction Kit7
BTQAirway, Nasopharyngeal5

GMDN & GCC registration

  • GMDN code 45036 · non‑implantable
  • Single‑use 95% · sterile 87% · Rx‑only 69% · 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

Lumen/Inner Diameter (Millimeter) · 15Total Volume (Milliliter) · 8

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

How many laryngeal mask airway, single-use products are registered in the US?

951 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laryngeal mask airway, single-use", from 26 companies. The largest labeler is Teleflex Incorporated with 52% of records.

Which FDA product codes apply?

CAE (AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY), CAE (Airway, Oropharyngeal, Anesthesiology), BTR (Tube, tracheal (w/wo connector)), FMF (Syringe, piston)

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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