FDA.reportPublic FDA data

N/A

Primary DI
04710810084669
Brand
N/A
Company
GALEMED CORPORATION
Model
2437
Catalog number
AV0002
Device description
Adj. PEEP Valve, 5~20cmH2O
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810084667PackageGS150In Commercial Distribution
04710810084669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081008466744710810084667
04710810084669047108100846694710810084669

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
04710810084621N/A2339AR00822026-03-05
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
10641043561782CPR-2 BagMERCURY ENTERPRISES, INC.BTM2026-11-05
10889483653371AirlifeVENTLAB, LLCBTM2026-10-15
10889483654286AirlifeVENTLAB, LLCBTM2026-10-15
10889483654293AirlifeVENTLAB, LLCBTM2026-10-15
10889483654309AirlifeVENTLAB, LLCBTM2026-10-15
10889483654316AirlifeVENTLAB, LLCBTM2026-10-15
10889483631522AirFlow™VENTLAB, LLCBTM2025-02-03
10889483555675VentlabVENTLAB, LLCBTM2024-03-12
10889483555743VentlabVENTLAB, LLCBTM2024-03-12
10889483555750VentlabVENTLAB, LLCBTM2024-03-12
10889483555767VentlabVENTLAB, LLCBTM2024-03-12
10889483555774VentlabVENTLAB, LLCBTM2024-03-12
10889483555798VentlabVENTLAB, LLCBTM2024-03-12
10889483555804VentlabVENTLAB, LLCBTM2024-03-12
10889483555842VentlabVENTLAB, LLCBTM2024-03-12
10889483555859VentlabVENTLAB, LLCBTM2024-03-12
10889483565643AirFlowVENTLAB, LLCBTM2023-12-14
10889483111185VentlabVENTLAB, LLCBTM2023-07-12
10889483073315VentlabVENTLAB, LLCBTM2023-06-28
10889483167083VentlabVENTLAB, LLCBTM2023-06-28
10889483077573Ventlab, LLCVENTLAB, LLCBTM2023-06-26
10889483172230Ventlab, LLCVENTLAB, LLCBTM2023-06-26
00840117326002RespO2 Manual Pulmonary Resuscitator (MPR)Dynarex CorporationBTM2023-01-09
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
06946430410832CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410856CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410870CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10190752141308AirLife™AIRLIFEBTM2021-05-03