Consulting Wallah › Device Explorer › Equipment & monitoring › Airway pressure monitor, non-powered
Device Explorer · FDA GUDID · GMDN 46634

Airway pressure monitor, non-powered

A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in re

US‑registered devices135in commercial distribution
Companies27labelers on GUDID
Single‑use64%of device records
Sterile3%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Ventlab, Llc2519%
Anesthesia Associates, Inc.2418%
Instrumentation Industries, Incorporated2317%
Mercury Enterprises, Inc.2216%
Besmed Health Business Corp.64%
D R Burton Healthcare, Llc54%
Tianjin Medis Medical Device Co.,Ltd.32%
Galemed Corporation32%

Top labelers

CompanyDevicesShare
Ventlab, Llc2519%
Anesthesia Associates, Inc.2418%
Instrumentation Industries, Incorporated2317%
Mercury Enterprises, Inc.2216%
Besmed Health Business Corp.64%
D R Burton Healthcare, Llc54%
Tianjin Medis Medical Device Co.,Ltd.32%
Galemed Corporation32%
Engineered Medical Systems Inc21%
Pulmodyne Inc21%
Icu Medical, Inc.21%
Airlife21%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

O-Two Disposable Pressure manometer 0-20cmH2OThe BAG ManometerMedisAmbu® Disposable Pressure ManometerFlexicareRESUSCITATOR MANOMETER POP OFF ADULTRESUSCITATOR MANOMETER POP OFF CHILDRESUSCITATOR MANOMETER POP OFF 60cmH2O(PC)HEADSTARN/AGaleMedAdult Sotair DeviceDisposable Pressure ManometerOxyPAPOxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMOxyPAP PAP DEVICE w/o MANOMETER

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

FDA product codes

CodeNameDevices
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)58
CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)26
NHKResuscitator, manual, non self-inflating25
BXRMeter, Airway Pressure (Inspiratory Force)16
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR 7
BWFSpirometer, Therapeutic (Incentive)5

GMDN & GCC registration

  • GMDN code 46634 · non‑implantable
  • Single‑use 64% · sterile 3% · Rx‑only 94% · 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 (Liter) · 25Length (Millimeter) · 2Weight (Gram) · 2Outer Diameter (Millimeter) · 2

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

No closely related category with 50+ devices.

How many airway pressure monitor, non-powered products are registered in the US?

135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Airway pressure monitor, non-powered", from 27 companies. The largest labeler is Ventlab, Llc with 19% of records.

Which FDA product codes apply?

CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), CAP (MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)), NHK (Resuscitator, manual, non self-inflating), BXR (Meter, Airway Pressure (Inspiratory Force))

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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