Consulting Wallah › Device Explorer › Other devices › Fixed-regulator oxygen refillable cylinder
Device Explorer · FDA GUDID · GMDN 31760

Fixed-regulator oxygen refillable cylinder

A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and

US‑registered devices66in commercial distribution
Companies7labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Mada Medical Products, Inc3655%
Drive Devilbiss Healthcare914%
Devilbiss Healthcare Llc812%
Mv Life Llc711%
Inovo, Inc.35%
Sunset Healthcare Solutions, Inc.23%
Allied Medical, Llc12%

Top labelers

CompanyDevicesShare
Mada Medical Products, Inc3655%
Drive Devilbiss Healthcare914%
Devilbiss Healthcare Llc812%
Mv Life Llc711%
Inovo, Inc.35%
Sunset Healthcare Solutions, Inc.23%
Allied Medical, Llc12%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DeVilbissRespiratory AccessoryOxygen RegulatorInovoMADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCBONSAIROSCOELifogenLIFE®StartSystemLIFE®OxygenPacLIFE®SoftPac

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 Cylinder43
CAWGenerator, Oxygen, Portable23
NFBConserver, Oxygen18
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)10
CAWGenerator, oxygen, portable5
CANREGULATOR, PRESSURE, GAS CYLINDER3

GMDN & GCC registration

  • GMDN code 31760 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 20% · OTC 12%
  • 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) · 7

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

How many fixed-regulator oxygen refillable cylinder products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fixed-regulator oxygen refillable cylinder", from 7 companies. The largest labeler is Mada Medical Products, Inc with 55% of records.

Which FDA product codes apply?

CAN (Regulator, Pressure, Gas Cylinder), CAW (Generator, Oxygen, Portable), NFB (Conserver, Oxygen), BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment))

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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