Consulting Wallah › Device Explorer › Other devices › Inspiratory/expiratory limb respiratory tubing, re
Device Explorer · FDA GUDID · GMDN 61833

Inspiratory/expiratory limb respiratory tubing, reusable

A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positi

US‑registered devices207in commercial distribution
Companies11labelers on GUDID
Single‑use59%of device records
Sterile0%labelled sterile
Prescription21%Rx‑only share
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Share of device records

Sunset Healthcare Solutions, Inc.14470%
Fisher & Paykel Healthcare Limited2110%
Vyaire Medical, Inc.126%
Drive Devilbiss Healthcare105%
Airlife Finland Oy84%
Vincent Medical Manufacturing Co., Limited42%
Flexicare Medical Limited21%
Exceleron Medical, Inc.21%

Top labelers

CompanyDevicesShare
Sunset Healthcare Solutions, Inc.14470%
Fisher & Paykel Healthcare Limited2110%
Vyaire Medical, Inc.126%
Drive Devilbiss Healthcare105%
Airlife Finland Oy84%
Vincent Medical Manufacturing Co., Limited42%
Flexicare Medical Limited21%
Exceleron Medical, Inc.21%
Medline Industries, Inc.21%
Sleepres, Llc10%
Fresca Medical, Inc.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

"Smoothbore Tube Pediatric 1.1m (43"") Reusable "Smoothbore Tube Pediatric 1.1m (43"") Reusable V-ComCPAP FilterCPAP TubingCPAP KitAerosolCPAP Tube 6 ft6 FT Standard TubingCPAP Tube 6ftSlim CPAP Tubes 6ft6 Month CPAP Kit3 Month CPAP KitCPAP Mask CushionOxygen KitCPAP Kit for DreamStation

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

FDA product codes

CodeNameDevices
BYXTubing, Pressure And Accessories114
BZOSet, Tubing And Support, Ventilator (W Harness)31
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR 14
BYXTUBING, PRESSURE AND ACCESSORIES10
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)8
OFPAnesthesia breathing circuit kit (adult & pediatric)8

GMDN & GCC registration

  • GMDN code 61833 · non‑implantable
  • Single‑use 59% · sterile 0% · Rx‑only 21% · OTC 2%
  • 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 inspiratory/expiratory limb respiratory tubing, reusable products are registered in the US?

207 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inspiratory/expiratory limb respiratory tubing, reusable", from 11 companies. The largest labeler is Sunset Healthcare Solutions, Inc. with 70% of records.

Which FDA product codes apply?

BYX (Tubing, Pressure And Accessories), BZO (Set, Tubing And Support, Ventilator (W Harness)), BZE (HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR ), BYX (TUBING, PRESSURE AND ACCESSORIES)

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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