Consulting Wallah › Device Explorer › Other devices › Pulmonary resuscitator, pneumatic, reusable
Device Explorer · FDA GUDID · GMDN 13366

Pulmonary resuscitator, pneumatic, reusable

A device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical

US‑registered devices102in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
ShareLinkedIn

Share of device records

Besmed Health Business Corp.5958%
Allied Medical, Llc1515%
O-Two Medical Technologies Inc1414%
Icu Medical, Inc.55%
Fisher & Paykel Healthcare Limited33%
Flexicare Medical Limited22%
International Biomedical, Ltd.22%
Datex-Ohmeda, Inc.22%

Top labelers

CompanyDevicesShare
Besmed Health Business Corp.5958%
Allied Medical, Llc1515%
O-Two Medical Technologies Inc1414%
Icu Medical, Inc.55%
Fisher & Paykel Healthcare Limited33%
Flexicare Medical Limited22%
International Biomedical, Ltd.22%
Datex-Ohmeda, Inc.22%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CAREvent PARCAFREvent ALS+ CPAPCAREvent ALS+CAREvent DRACAREvent CACAREvent ALSCARevent ALSCAREvent EMTNeoPIP Infant Resuscitator Universal Mounting BrNeoPIP Infant ResuscitatorSILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40SILICONE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CSILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFFSILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40SILICONE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CSILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60

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)64
BTLVentilator, Emergency, Powered (Resuscitator)25
BTLVentilator, emergency, powered (resuscitator)6
FMTWarmer, Infant Radiant3
BTMVentilator, emergency, manual (resuscitator)1
CBKVentilator, Continuous, Facility Use1

GMDN & GCC registration

  • GMDN code 13366 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 96% · 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

Weight (Kilogram) · 7Height (Inch) · 7Width (Inch) · 7Length (Inch) · 7

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

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

102 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary resuscitator, pneumatic, reusable", from 8 companies. The largest labeler is Besmed Health Business Corp. with 58% of records.

Which FDA product codes apply?

BTM (Ventilator, Emergency, Manual (Resuscitator)), BTL (Ventilator, Emergency, Powered (Resuscitator)), BTL (Ventilator, emergency, powered (resuscitator)), FMT (Warmer, Infant Radiant)

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.

How do I get quotes?

Add pulmonary resuscitator, pneumatic, reusable to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Pulmonary resuscitator, pneumatic, reusable

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying pulmonary resuscitator, pneumatic, reusable for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →