Consulting Wallah › Device Explorer › Other devices › Breathing circuit bag, single-use
Device Explorer · FDA GUDID · GMDN 34877

Breathing circuit bag, single-use

A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a max

US‑registered devices327in commercial distribution
Companies29labelers on GUDID
Single‑use99%of device records
Sterile2%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Shandong Jinlai Huanhai Medical Technology Co., Ltd.12037%
Teleflex Incorporated7222%
King Systems Corporation3611%
Drägerwerk Ag & Co. Kgaa186%
Instrumentation Industries, Incorporated82%
Westmed, Inc.72%
Airlife72%
Airlife Finland Oy72%

Top labelers

CompanyDevicesShare
Shandong Jinlai Huanhai Medical Technology Co., Ltd.12037%
Teleflex Incorporated7222%
King Systems Corporation3611%
Drägerwerk Ag & Co. Kgaa186%
Instrumentation Industries, Incorporated82%
Westmed, Inc.72%
Airlife72%
Airlife Finland Oy72%
Flexicare Medical Limited52%
Endure Industries52%
Maquet Critical Care Ab41%
Galemed Xiamen Co., Ltd.41%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Breathing bag anest disp 2L complBreathing bag anest disp 1L complBreathing bag anest disp 0.5L,complBreathing bag anest disp 3L complBreathing bagsMindrayReservoir Bag 2 Litre with 22mm Female ConnectorReservoir Bag 2L Latex with 22mm F ConnectorReservoir Bag 3 Litre with 22mm Female ConnectorReservoir Bag 1 Litre with 22mm Female ConnectorReservoir Bag 0.5 Litre with 22mm Female ConnectRESERVOIR BAG, 2L WITH ANTI OCCLUSION CAGE MOUNTRESERVOIR BAG, 3L WITH ANTI OCCLUSION CAGE MOUNTBREATHING BAG single use 3000BREATHING BAG single use 2000BREATHING BAG single use 1000

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

FDA product codes

CodeNameDevices
BTCBag, Reservoir204
BTCBAG, RESERVOIR123
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)11
BZOSet, Tubing And Support, Ventilator (W Harness)9
CAHFilter, bacterial, breathing-circuit3
CBNAPPARATUS, GAS-SCAVENGING2

GMDN & GCC registration

  • GMDN code 34877 · non‑implantable
  • Single‑use 99% · sterile 2% · Rx‑only 50% · 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) · 6Height (Inch) · 1Width (Inch) · 1Length (Inch) · 1

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

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

327 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Breathing circuit bag, single-use", from 29 companies. The largest labeler is Shandong Jinlai Huanhai Medical Technology Co., Ltd. with 37% of records.

Which FDA product codes apply?

BTC (Bag, Reservoir), BTC (BAG, RESERVOIR), CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), BZO (Set, Tubing And Support, Ventilator (W Harness))

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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