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Device Explorer · FDA GUDID · GMDN 60657

Non-rebreathing valve, single-use

A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is availabl

US‑registered devices183in commercial distribution
Companies14labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Medline Industries, Inc.8748%
Certified Safety Manufacturing, Inc.5430%
Teleflex Incorporated127%
Bound Tree Medical, Llc74%
Intersurgical Incorporated63%
Xiamen Compower Medical Tech. Co., Ltd42%
Galemed Corporation42%
Galemed Xiamen Co., Ltd.21%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.8748%
Certified Safety Manufacturing, Inc.5430%
Teleflex Incorporated127%
Bound Tree Medical, Llc74%
Intersurgical Incorporated63%
Xiamen Compower Medical Tech. Co., Ltd42%
Galemed Corporation42%
Galemed Xiamen Co., Ltd.21%
Drägerwerk Ag & Co. Kgaa21%
Gfa Production (Xiamen) Co., Ltd.11%
Flexicare Medical Limited11%
Fim Medical11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GFA ProductionCompowerN/AFlexicareT-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVEST-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVEST-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVECONNECTOR, 22M, 22M WITH ONE-WAY VALVEONE-WAY DIRECTIONAL VALVE 22M FLOW IN-22F FLOW OGaleMedExp-Valve disp RFIDExp-Valve disposableHUDSON RCITRAPPERNegative Inspiratory Force T PieceCuraplex

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

FDA product codes

CodeNameDevices
CAICircuit, breathing (w connector, adaptor, y piece)76
CBPValve, non-rebreathing54
LRRFirst Aid Kit with drug37
EFQGAUZE/SPONGE, INTERNAL35
KGXTape and bandage, adhesive33
HMPPAD, EYE21

GMDN & GCC registration

  • GMDN code 60657 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 66% · 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

Total Volume (Liter) · 5

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

How many non-rebreathing valve, single-use products are registered in the US?

183 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-rebreathing valve, single-use", from 14 companies. The largest labeler is Medline Industries, Inc. with 48% of records.

Which FDA product codes apply?

CAI (Circuit, breathing (w connector, adaptor, y piece)), CBP (Valve, non-rebreathing), LRR (First Aid Kit with drug), EFQ (GAUZE/SPONGE, INTERNAL)

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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