Consulting Wallah › Device Explorer › Equipment & monitoring › Ventilator breathing circuit, single-use
Device Explorer · FDA GUDID · GMDN 37706

Ventilator breathing circuit, single-use

An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-

US‑registered devices1,017in commercial distribution
Companies48labelers on GUDID
Single‑use95%of device records
Sterile6%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Teleflex Incorporated13213%
Airlife12913%
Vyaire Medical, Inc.848%
Fisher & Paykel Healthcare Limited808%
Flexicare Medical Limited666%
Intersurgical Incorporated566%
Medline Industries, Inc.515%
Drägerwerk Ag & Co. Kgaa465%

Top labelers

CompanyDevicesShare
Teleflex Incorporated13213%
Airlife12913%
Vyaire Medical, Inc.848%
Fisher & Paykel Healthcare Limited808%
Flexicare Medical Limited666%
Intersurgical Incorporated566%
Medline Industries, Inc.515%
Drägerwerk Ag & Co. Kgaa465%
Instrumentation Industries, Incorporated394%
Flight Medical Innovations Ltd364%
Respironics, Inc.313%
Westmed, Inc.303%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

O-TwoBreathing system 15mm HME Disp 1.2mBreath syst 22mm HME & MR 3M DispBreath syst 10mm HME Disp1.2mBreath syst 10mm HME & MR 3M DispBreath syst 15mm HME & MR 3M DispBreathing system 22mm HME Disp 1.5mVivo SeriesVentoux Patient CircuitN/AMindrayHyperinflation AMBUAmbu Hyper SystemHyperinflation (AMBU)Hyperinflation (ABMU)Hybernite RT

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

FDA product codes

CodeNameDevices
BZOSet, Tubing And Support, Ventilator (W Harness)234
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or 129
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)123
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR 116
OGGHumidifier nebulizer kit95
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)92

GMDN & GCC registration

  • GMDN code 37706 · non‑implantable
  • Single‑use 95% · sterile 6% · Rx‑only 80% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 27Length (Centimeter) · 25Length (Feet) · 12Length (Inch) · 6Weight (Gram) · 4Length (Meter) · 2

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

How many ventilator breathing circuit, single-use products are registered in the US?

1,017 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ventilator breathing circuit, single-use", from 48 companies. The largest labeler is Teleflex Incorporated with 13% of records.

Which FDA product codes apply?

BZO (Set, Tubing And Support, Ventilator (W Harness)), BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or ), CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), BZE (HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR )

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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