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Device Explorer · FDA GUDID · GMDN 17591

Pulmonary resuscitator, manual, reusable

A 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 reservoir, tubing, a

US‑registered devices155in commercial distribution
Companies19labelers on GUDID
Single‑use8%of device records
Sterile3%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Laerdal Medical As3321%
Mercury Enterprises, Inc.1812%
Allied Medical, Llc1610%
Ambu A/S149%
O-Two Medical Technologies Inc128%
Enter Medical Corporation106%
Teleflex Incorporated106%
Besmed Health Business Corp.96%

Top labelers

CompanyDevicesShare
Laerdal Medical As3321%
Mercury Enterprises, Inc.1812%
Allied Medical, Llc1610%
Ambu A/S149%
O-Two Medical Technologies Inc128%
Enter Medical Corporation106%
Teleflex Incorporated106%
Besmed Health Business Corp.96%
Galemed Xiamen Co., Ltd.64%
Accutron, Inc.53%
Archeon43%
Med-Tech Resource, Llc32%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EASY GRIPSMART BAG MOSAMRT BAG MONeoNatalie Resuscitator (US)NeoNatalie Complete LightNeoNatalie Complete Dark (US)NeoNatalie Complete Light (US)LSR Adult Cpl. w/Masks in Display Case (EUR)LSR Adult Cpl. w/Masks in Compact Case (EUR)LSR Adult Cpl. w/Masks, in Compact Case (IE)LSR Adult Standard w/Masks in CartonLSR Adult Standard w/Mask, in carton (IE)LSR Adult Complete w/Masks in Carton (EUR)LSR Adult Complete w/Masks, in Carton (IE)LSR Adult Basic wo/Mask in Carton (EUR)LSR Adult Basic wo/Mask in Carton (IE)

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)149
BTMVentilator, emergency, manual (resuscitator)44
BYMTube, Thorpe, Uncompensated1

GMDN & GCC registration

  • GMDN code 17591 · non‑implantable
  • Single‑use 8% · sterile 3% · Rx‑only 83% · 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

Length (Inch) · 4Weight (Kilogram) · 2

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

How many pulmonary resuscitator, manual, reusable products are registered in the US?

155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary resuscitator, manual, reusable", from 19 companies. The largest labeler is Laerdal Medical As with 21% of records.

Which FDA product codes apply?

BTM (Ventilator, Emergency, Manual (Resuscitator)), BTM (Ventilator, emergency, manual (resuscitator)), BYM (Tube, Thorpe, Uncompensated)

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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