FDA.reportPublic FDA data

Mask, Adult Aerosol, Vented

Primary DI
10709078003766
Brand
Mask, Adult Aerosol, Vented
Company
WESTMED, INC.
Model
0250
Device description
Mask, Adult Aerosol, Vented
Published
2017-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078003766PackageGS150In Commercial Distribution
00709078003769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800376610709078003766
00709078003769007090780037697090780037690709078003769

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, non-rebreathingA flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078000515Nebulizer02232016-11-24
00709078000560Nebulizer03252016-11-24
00709078000614Nebulizer02052016-11-24
00709078006197VixOne Nebulizer02332018-11-30
20889483528614AMBU Hyperinflation System900 000 6142026-03-05
20889483528737AMBU Hyperinflation System900 000 6172026-03-05
20889483528751AMBU Hyperinflation System900 000 6182026-03-05
20889483528867AMBU Hyperinflation System900 000 6242026-03-05
20889483528942AMBU Hyperinflation System900 000 6282026-03-05
20889483568795AMBU Hyperinflation System900 000 6012026-03-05
20889483542801AMBU Hyperinflation System900 000 6022026-03-05
20889483542849AMBU Hyperinflation System900 000 6042026-03-05
20889483542863AMBU Hyperinflation System900 000 6052026-03-05
20889483542887AMBU Hyperinflation System900 000 6062026-03-05
20889483542924AMBU Hyperinflation System900 000 6092026-03-05
20889483542962AMBU Hyperinflation System900 000 6112026-03-05
10709078000574VixOneVOID 02482025-11-24
00709078049996FilterVoid OU812b2025-09-23
00709078050008FilterVoid OU812a2025-09-23
10709078008402Flex Extenders7-51322024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501348OXYGEN MASK Single Use Size 4 with nebulizerASSOMEDIKA, OOOBYG2026-05-26
04816415501355OXYGEN MASK Single Use Size 4 with bagASSOMEDIKA, OOOBYG2026-05-26
04816415501362OXYGEN MASK Single Use Size 4ASSOMEDIKA, OOOBYG2026-05-26
06923980112577MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112584MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112591MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112607MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112690MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112553MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112560MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112645MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112652MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112669MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112706MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112713MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
07045432120462Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120479Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120486Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120493Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120509Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
20885632467407HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467414HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467469HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
07045432115987The BAG Mask size 1Laerdal Medical ASBYG2026-01-14
07045432115994The BAG Mask size 2 Laerdal Medical ASBYG2026-01-14
07045432116007The BAG Mask size 3 Laerdal Medical ASBYG2026-01-14
07045432116014The BAG Mask size 4Laerdal Medical ASBYG2026-01-14
07045432116021The BAG Mask size 5Laerdal Medical ASBYG2026-01-14
20889483221669Performance Home MedicalSUNMED, LLCBYG2025-12-31
20889483227265BiFLo™SUNMED, LLCBYG2025-12-30