Consulting Wallah › Device Explorer › Equipment & monitoring › Ventilator breathing circuit, reusable
Device Explorer · FDA GUDID · GMDN 37705

Ventilator breathing circuit, reusable

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, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a pati

US‑registered devices287in commercial distribution
Companies23labelers on GUDID
Single‑use14%of device records
Sterile0%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Instrumentation Industries, Incorporated11841%
Resmed Pty Ltd259%
Drägerwerk Ag & Co. Kgaa238%
Respironics, Inc.217%
Newport Medical Instruments, Inc.197%
Abmrc Llc145%
Fisher & Paykel Healthcare Limited103%
Breas Medical Ab72%

Top labelers

CompanyDevicesShare
Instrumentation Industries, Incorporated11841%
Resmed Pty Ltd259%
Drägerwerk Ag & Co. Kgaa238%
Respironics, Inc.217%
Newport Medical Instruments, Inc.197%
Abmrc Llc145%
Fisher & Paykel Healthcare Limited103%
Breas Medical Ab72%
Intersurgical Incorporated72%
Maquet Critical Care Ab62%
Plastiflex Group62%
Medline Industries, Inc.62%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Flextub Hytrel 15mm 15cmHytrel slang 10mm 30cmPat syst 10mm HME Hytrel Reus 1.5mPat syst 15mm HME Hytrel Reus 1.5mPat syst 22mm HME HME Si Reus 1.5mPat syst 22mm HME Hytrel Reus 1.5mVivo 1/2, Vivo 3Vivo SeriesHeated TubingBreathing Tube (L1)MindrayHyberniteClassic22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATH22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTE22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTE

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)184
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)33
CAICircuit, breathing (w connector, adaptor, y piece)28
BZDVentilator, Non-Continuous (Respirator)22
NHJDevice, Positive Pressure Breathing, Intermittent15
CBKVENTILATOR, CONTINUOUS, FACILITY USE15

GMDN & GCC registration

  • GMDN code 37705 · non‑implantable
  • Single‑use 14% · sterile 0% · Rx‑only 39% · OTC 47%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 2Lumen/Inner Diameter (Millimeter) · 1Length (Centimeter) · 1

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

How many ventilator breathing circuit, reusable products are registered in the US?

287 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ventilator breathing circuit, reusable", from 23 companies. The largest labeler is Instrumentation Industries, Incorporated with 41% of records.

Which FDA product codes apply?

BZO (Set, Tubing And Support, Ventilator (W Harness)), CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), CAI (Circuit, breathing (w connector, adaptor, y piece)), BZD (Ventilator, Non-Continuous (Respirator))

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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