FDA.reportPublic FDA data

N/A

Primary DI
04710810084621
Brand
N/A
Company
GALEMED CORPORATION
Model
2339
Catalog number
AR0082
Device description
DispoBag, Adult w/Pop-Off, Reservoir
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810084629PackageGS112In Commercial Distribution
04710810084621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081008462944710810084629
04710810084621047108100846214710810084621

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Regulatory Flags#

DUNS number
656854379
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710810085550N/A71053AB01252026-03-05
24710810110171N/A5428AM00342026-03-05
24710810112458N/A5429AM00352026-03-05
04710810080586N/A3564AD00492026-03-05
04710810080838N/A5313AM00282026-03-05
04710810081781N/A5304AM00942026-03-05
04710810081811N/A5305AM00952026-03-05
04710810082122N/A3565AD00512026-03-05
04710810082252N/A5315AM00302026-03-05
04710810082269N/A5314AM00292026-03-05
04710810082405N/A5311AM00262026-03-05
04710810082412N/A5312AM00272026-03-05
04710810082429N/A5316AM00312026-03-05
04710810082481N/A5306AM00962026-03-05
04710810082962N/A3551AD00022026-03-05
04710810083327N/A74112AC00532026-03-05
04710810084669N/A2437AV00022026-03-05
04710810084850N/A75045AC01712026-03-05
04710810084942N/A0015AM00422026-03-05
04710810084980N/A3566AD00532026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344097401MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097418MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097425MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097432MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097449MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100446MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100453MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100477MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100484MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344110902MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100460MEDLINEMEDLINE INDUSTRIES, INC.BTM2024-12-05
10195327558598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTM2023-12-21
10193489139303MedlineMEDLINE INDUSTRIES, INC.BTM2023-02-04
10193489189162MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489189179MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489181937MedlineMEDLINE INDUSTRIES, INC.BTM2022-11-10
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489003123MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-22
10193489092400MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-12
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001952MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489009767MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003116MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003758MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10190752141308AirLife™AIRLIFEBTM2021-05-03
10190752141315AirLife™AIRLIFEBTM2021-05-03
10190752141346AirLife™AIRLIFEBTM2021-05-03