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Device Explorer · FDA GUDID · GMDN 47083

Portable electric ventilator

A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volume

US‑registered devices653in commercial distribution
Companies10labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Respironics, Inc.51979%
Resmed Pty Ltd396%
Respironics California, Inc.325%
Ventec Life Systems, Inc.315%
Breas Medical Ab142%
Ventis Medical Inc.122%
Inogen, Inc.20%
Thornhill Research Inc20%

Top labelers

CompanyDevicesShare
Respironics, Inc.51979%
Resmed Pty Ltd396%
Respironics California, Inc.325%
Ventec Life Systems, Inc.315%
Breas Medical Ab142%
Ventis Medical Inc.122%
Inogen, Inc.20%
Thornhill Research Inc20%
Compal Electronics, Inc.10%
Nihon Kohden Orangemed, Inc.10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vivo 45 LSVivo 3Vivo 1/2Vivo 65Vivo 1/2, Vivo 3Vivo 50, VIvo 65BreathePal BilevelPHILIPSPhilips RespironicsVOCSNVOCSN Roll StandVOCSN Patient Breathing PackageVOCSN Carry BagVOCSN Nebulizer FiltersVOCSN Removable Battery Quick ChargerVOCSN-VC

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

FDA product codes

CodeNameDevices
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING360
DQAOximeter113
CBKVENTILATOR, CONTINUOUS, FACILITY USE103
MNTVentilator, continuous, minimal ventilatory support, facilit92
CBKVentilator, Continuous, Facility Use72
NOUCONTINUOUS, VENTILATOR, HOME USE65

GMDN & GCC registration

  • GMDN code 47083 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 93% · 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 portable electric ventilator products are registered in the US?

653 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Portable electric ventilator", from 10 companies. The largest labeler is Respironics, Inc. with 79% of records.

Which FDA product codes apply?

MNS (VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING), DQA (Oximeter), CBK (VENTILATOR, CONTINUOUS, FACILITY USE), MNT (Ventilator, continuous, minimal ventilatory support, facilit)

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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