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Device Explorer · FDA GUDID · GMDN 35176

Anaesthesia face mask, reusable

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 devices162in commercial distribution
Companies17labelers on GUDID
Single‑use25%of device records
Sterile3%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Parker-Hannifin Corporation3220%
Anesthesia Associates, Inc.2918%
Flexicare Medical Limited2515%
Vbm Medizintechnik Gmbh159%
O-Two Medical Technologies Inc96%
Galemed Xiamen Co., Ltd.74%
Foremount Enterprise Co., Ltd.74%
Maquet Critical Care Ab64%

Top labelers

CompanyDevicesShare
Parker-Hannifin Corporation3220%
Anesthesia Associates, Inc.2918%
Flexicare Medical Limited2515%
Vbm Medizintechnik Gmbh159%
O-Two Medical Technologies Inc96%
Galemed Xiamen Co., Ltd.74%
Foremount Enterprise Co., Ltd.74%
Maquet Critical Care Ab64%
Galemed Corporation64%
Drägerwerk Ag & Co. Kgaa64%
Accutron, Inc.53%
Sharn Anesthesia42%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

O-TwoAnest mask reuse,size 5 with MAQUETAnest mask reuse,size 1 with MAQUETAnest mask reuse,size 2 with MAQUETAnest mask reuse,size 0 with MAQUETAnest mask reuse,size 4 with MAQUETAnest mask reuse,size 3 with MAQUETAmbuAnesthesia Face Mask Silicone Reusable Large AduAnesthesia Face Mask Silicone Reusable Adult SizAnesthesia Face Mask Silicone Reusable Large ChiAnesthesia Face Mask Silicone Reusable Medium ChAnesthesia Face Mask Silicone Reusable Small ChiAnesthesia Face Mask Silicone Reusable Neonatal Anesthesia Face Mask Silicone Reusable Large AduAnesthesia Face Mask Silicone Reusable Adult Siz

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, Anesthetic88
BSJMASK, GAS, ANESTHETIC33
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)17
KHAMask, Scavenging16
BYGMask, Oxygen6
NHKResuscitator,Manual,Non Self-Inflating6

GMDN & GCC registration

  • GMDN code 35176 · non‑implantable
  • Single‑use 25% · sterile 3% · Rx‑only 79% · OTC 2%
  • 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) · 5Total Volume (Milliliter) · 3

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

How many anaesthesia face mask, reusable products are registered in the US?

162 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Anaesthesia face mask, reusable", from 17 companies. The largest labeler is Parker-Hannifin Corporation with 20% of records.

Which FDA product codes apply?

BSJ (Mask, Gas, Anesthetic), BSJ (MASK, GAS, ANESTHETIC), CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), KHA (Mask, Scavenging)

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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