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Device Explorer · FDA GUDID · GMDN 37709

Breathing circuit bag, reusable

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 devices113in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile4%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Anesthesia Associates, Inc.6759%
Vbm Medizintechnik Gmbh109%
Flexicare Medical Limited98%
Maquet Critical Care Ab76%
Galemed Xiamen Co., Ltd.54%
Assomedika, Ooo44%
Drägerwerk Ag & Co. Kgaa44%
Sunmed, Llc33%

Top labelers

CompanyDevicesShare
Anesthesia Associates, Inc.6759%
Vbm Medizintechnik Gmbh109%
Flexicare Medical Limited98%
Maquet Critical Care Ab76%
Galemed Xiamen Co., Ltd.54%
Assomedika, Ooo44%
Drägerwerk Ag & Co. Kgaa44%
Sunmed, Llc33%
Parker-Hannifin Corporation22%
Accutron, Inc.22%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Breath bag Anest Reus 1LBreath bag Anest Reus 0.5LBreath bag set Anest 15mm HytrelBreath bag set Anest 10mm HytrelBreath bag Anest Reus 3LBreath bag set Anest 22mm HytrelBreath bag Anest Reus 2LMindraySilicone Reservoir Bag 3L (600 040 003GE)Silicone Reservoir Bag 2L (600 040 002GE)Silicone Reservoir Bag 1L (600 040 001GE)Silicone Reservoir Bag 0.5L (600 040 005GE)Scavenging Bag Reusable 3L 30M/22F (038-81-835RSilicone Reservoir Bag 3L (600 040 003eaGE)Silicone Reservoir Bag 2L (600 040 002eaGE)Silicone Reservoir Bag 1L (600 040 001eaGE)

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

FDA product codes

CodeNameDevices
BTCBAG, RESERVOIR67
BTCBag, Reservoir58
BTMVentilator, Emergency, Manual (Resuscitator)4

GMDN & GCC registration

  • GMDN code 37709 · non‑implantable
  • Single‑use 0% · sterile 4% · Rx‑only 81% · OTC 4%
  • 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) · 70Lumen/Inner Diameter (Millimeter) · 10Total Volume (Milliliter) · 10

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

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

113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Breathing circuit bag, reusable", from 10 companies. The largest labeler is Anesthesia Associates, Inc. with 59% of records.

Which FDA product codes apply?

BTC (BAG, RESERVOIR), BTC (Bag, Reservoir), BTM (Ventilator, Emergency, Manual (Resuscitator))

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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