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Device Explorer · FDA GUDID · GMDN 60944

Medical air cylinder regulator

A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical air cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working

US‑registered devices53in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

J. W. Harris Co., Inc.5298%
Icu Medical, Inc.12%

Top labelers

CompanyDevicesShare
J. W. Harris Co., Inc.5298%
Icu Medical, Inc.12%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

The Harris Products GroupPneupac

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

FDA product codes

CodeNameDevices
CANRegulator, Pressure, Gas Cylinder34
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated18
BTLVentilator, emergency, powered (resuscitator)1

GMDN & GCC registration

  • GMDN code 60944 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 2% · 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

No structured size data on the register.

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

How many medical air cylinder regulator products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical air cylinder regulator", from 2 companies. The largest labeler is J. W. Harris Co., Inc. with 98% of records.

Which FDA product codes apply?

CAN (Regulator, Pressure, Gas Cylinder), CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), BTL (Ventilator, emergency, powered (resuscitator))

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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