Consulting Wallah › Device Explorer › Gloves & PPE › Cardiopulmonary resuscitation mask, single-use
Device Explorer · FDA GUDID · GMDN 61326

Cardiopulmonary resuscitation mask, single-use

"A flexible, form-shaped device that is placed over a patient's mouth to administer ""mouth-to-mask"" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace ""mouth-to-mouth"" resuscitation theref

US‑registered devices193in commercial distribution
Companies36labelers on GUDID
Single‑use98%of device records
Sterile2%labelled sterile
Prescription46%Rx‑only share
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Share of device records

Xiamen Compower Medical Tech. Co., Ltd4322%
Certified Safety Manufacturing, Inc.179%
Laerdal Medical As158%
Flexicare Medical Limited116%
Bound Tree Medical, Llc116%
Rondex Products, Incorporated116%
B.L.S. Systems Limited116%
Acme United Corporation95%

Top labelers

CompanyDevicesShare
Xiamen Compower Medical Tech. Co., Ltd4322%
Certified Safety Manufacturing, Inc.179%
Laerdal Medical As158%
Flexicare Medical Limited116%
Bound Tree Medical, Llc116%
Rondex Products, Incorporated116%
B.L.S. Systems Limited116%
Acme United Corporation95%
Wuxi Emsrun Technology Co., Ltd.84%
Ambu A/S74%
Medsource International Llc63%
Dynarex Corporation42%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rescue BreatherKeyring 1pkg (10pcs) UDI for Foil Pack 6900LFS 1pkg (10pcs) for UDI for Foil Pack N0918LFS 1pkg (10pcs) for UDI for Foil Pack 6422LFS 1pkg (10pcs) for UDI for Foil Pack 6361LFS 1pcs for UDI for Foil Pack 6361Paediatric Pocket Mask w/Gloves & wipe, PolybagKeyring w/LFs x 25 (US) RedKeyring w/LFS x 25 (US) BlackKeyring w/LFS x 25 (US) YellowPaed. PM w/o wipe and gloves CPR Barrier Dev.Laerdal Paediatric PM w/Gloves in Red/BlackKeyring w/LFS x 25 CamouflageKeyring w/LFS x 25 MulticolourKeyring w/LFS x 25 Yellow.Paediatric Pocket Mask CPR Barrier Device

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

FDA product codes

CodeNameDevices
CBPValve, Non-Rebreathing80
BYGMask, Oxygen22
LYMDevice, Cpr Assist22
CBPValve, non-rebreathing19
BTMVentilator, Emergency, Manual (Resuscitator)16
BTMVentilator, emergency, manual (resuscitator)16

GMDN & GCC registration

  • GMDN code 61326 · non‑implantable
  • Single‑use 98% · sterile 2% · Rx‑only 46% · OTC 32%
  • 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 cardiopulmonary resuscitation mask, single-use products are registered in the US?

193 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiopulmonary resuscitation mask, single-use", from 36 companies. The largest labeler is Xiamen Compower Medical Tech. Co., Ltd with 22% of records.

Which FDA product codes apply?

CBP (Valve, Non-Rebreathing), BYG (Mask, Oxygen), LYM (Device, Cpr Assist), CBP (Valve, non-rebreathing)

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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