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Device Explorer · FDA GUDID · GMDN 36086

Pulmonary resuscitator, manual, single-use

A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservo

US‑registered devices2,174in commercial distribution
Companies37labelers on GUDID
Single‑use99%of device records
Sterile1%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Ventlab, Llc59727%
Mercury Enterprises, Inc.57026%
Ambu A/S2049%
Airlife1718%
Medline Industries, Inc.1135%
Icu Medical, Inc.1105%
Besmed Health Business Corp.633%
Teleflex Incorporated412%

Top labelers

CompanyDevicesShare
Ventlab, Llc59727%
Mercury Enterprises, Inc.57026%
Ambu A/S2049%
Airlife1718%
Medline Industries, Inc.1135%
Icu Medical, Inc.1105%
Besmed Health Business Corp.633%
Teleflex Incorporated412%
Bound Tree Medical, Llc332%
Engineered Medical Systems Inc261%
Allied Medical, Llc241%
Pulmodyne Inc191%

Company = labeler of record on GUDID. 37 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SMART BAG MOEASY GripEASY GRIPPocket BVM TM EXTPocket BVM TM NuMaskPocket BVM TM AirwayPocket BVM TM TacticalCyclone Pocket BVM 1000Pocket BVM ® cyclonePocket BVM O2 tubing 1000Pocket BVM TM O2 tubingPocket BVM TMThe BAG™ Resuscitator - Pediatric modelThe BAG™ Resuscitator - Adult modelThe BAG™ Resuscitator - Newborn modelThe BAG II Resuscitator Child w/mask #3

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

FDA product codes

CodeNameDevices
BTMVentilator, Emergency, Manual (Resuscitator)1,131
BTMVentilator, emergency, manual (resuscitator)663
NHKResuscitator,Manual,Non Self-Inflating210
OEVCardiopulmonary resuscitation aid kit201
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)86
BSJMask, Gas, Anesthetic82

GMDN & GCC registration

  • GMDN code 36086 · non‑implantable
  • Single‑use 99% · sterile 1% · Rx‑only 98% · 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

Total Volume (Milliliter) · 604Total Volume (Liter) · 114Weight (Kilogram) · 72Weight (Gram) · 31Circumference (Millimeter) · 2Total Volume (Microliter) · 1

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

How many pulmonary resuscitator, manual, single-use products are registered in the US?

2,174 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary resuscitator, manual, single-use", from 37 companies. The largest labeler is Ventlab, Llc with 27% of records.

Which FDA product codes apply?

BTM (Ventilator, Emergency, Manual (Resuscitator)), BTM (Ventilator, emergency, manual (resuscitator)), NHK (Resuscitator,Manual,Non Self-Inflating), OEV (Cardiopulmonary resuscitation aid kit)

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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