Consulting Wallah › Device Explorer › Gloves & PPE › Laryngeal mask airway, reusable
Device Explorer · FDA GUDID · GMDN 45035

Laryngeal mask airway, reusable

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 devices140in commercial distribution
Companies6labelers on GUDID
Single‑use7%of device records
Sterile44%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Teleflex Incorporated7151%
Sourcemark, Llc.4532%
Jiangxi Yiles Medical Co., Ltd86%
Fortune Medical Instrument Corp.86%
Flexicare Medical Limited75%
Medline Industries, Inc.11%

Top labelers

CompanyDevicesShare
Teleflex Incorporated7151%
Sourcemark, Llc.4532%
Jiangxi Yiles Medical Co., Ltd86%
Fortune Medical Instrument Corp.86%
Flexicare Medical Limited75%
Medline Industries, Inc.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ultra EXLMALMA AIRWAY MANAGEMENTLaryseal Multiple Laryngeal Mask Airway Size 1Laryseal Multiple Laryngeal Mask Airway Size 1.5Laryseal Multiple Laryngeal Mask Airway Size 2Laryseal Multiple Laryngeal Mask Airway Size 2.5Laryseal Multiple Laryngeal Mask Airway Size 3Laryseal Multiple Laryngeal Mask Airway Size 4Laryseal Multiple Laryngeal Mask Airway Size 5SourceMarkLaryngeal Mask TubeMedline

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, Anesthesiology69
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY68
BTRTube, tracheal (w/wo connector)8

GMDN & GCC registration

  • GMDN code 45035 · non‑implantable
  • Single‑use 7% · sterile 44% · Rx‑only 56% · 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 laryngeal mask airway, reusable products are registered in the US?

140 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laryngeal mask airway, reusable", from 6 companies. The largest labeler is Teleflex Incorporated with 51% of records.

Which FDA product codes apply?

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

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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