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Device Explorer · FDA GUDID · GMDN 61655

In-line CPAP set, non-nebulizing

A portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory em

US‑registered devices65in commercial distribution
Companies7labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription63%Rx‑only share
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Share of device records

Bound Tree Medical, Llc4163%
Vygon Corporation1218%
Engineered Medical Systems Inc58%
Drägerwerk Ag & Co. Kgaa23%
Pulmodyne Inc23%
Trudell Medical International23%
Ecleris12%

Top labelers

CompanyDevicesShare
Bound Tree Medical, Llc4163%
Vygon Corporation1218%
Engineered Medical Systems Inc58%
Drägerwerk Ag & Co. Kgaa23%
Pulmodyne Inc23%
Trudell Medical International23%
Ecleris12%

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

Brand names on the register (sample)

Seattle PAPSeattle PAP plusVYGONA-PEPAccuPAPCuraplexVersaPAP® Positive Airway Pressure DeviceVersaPAP™ Positive Airway Pressure DeviceECLERIS NIV HELMET

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

FDA product codes

CodeNameDevices
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE33
BYEAttachment, breathing, positive end expiratory pressure29
BYEAttachment, Breathing, Positive End Expiratory Pressure7
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)6
BWFSpirometer, Therapeutic (Incentive)4
OGLOxygen administration kit2

GMDN & GCC registration

  • GMDN code 61655 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 63% · 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 in-line cpap set, non-nebulizing products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "In-line CPAP set, non-nebulizing", from 7 companies. The largest labeler is Bound Tree Medical, Llc with 63% of records.

Which FDA product codes apply?

CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE), BYE (Attachment, breathing, positive end expiratory pressure), BYE (Attachment, Breathing, Positive End Expiratory Pressure), 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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