FDA.reportPublic FDA data

MedSource Aerosol Mask

Primary DI
00840155400276
Brand
MedSource Aerosol Mask
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-25083
Catalog number
Not Applicable
Device description
Aerosol Mask, Pediatric, Elongated
Published
2021-05-27
Public version status
New
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
00840155400276PackageGS150In Commercial Distribution
00840155400269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155400276008401554002768401554002760840155400276
00840155400269008401554002698401554002690840155400269

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
041674552
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
true
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
00816703025475MedSource Emesis BagMS-17360-RCSNot Applicable2021-05-10
00816703026526MedSource Airway DevicesMS-23908-RCSNot Applicable2021-05-18
00816703027172MedSource Traction SplintMS-TLS-3-RCSNot Applicable2021-08-16
00816703020838MedSource PRN, Male Luer PrositeMS-830112016-06-30
00816703021118MedSource NP Needle Free ConnectorMS-899792016-06-30
00840155421042Nasopharyngeal Airway1011-450002025-07-15
00840155401419MedSource CathetersMS-87414Not Applicable2023-01-09
00840155406179MedSource CathetersMS-87416Not Applicable2023-01-09
00840155413870MedSource CathetersMS-87420Not Applicable2023-01-09
00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
00840155413931MedSource CathetersMS-87424Not Applicable2023-01-09
00840155413962MedSource CathetersMS-874202Not Applicable2023-01-09
00840155413993MedSource Winged CathetersMS-84214WNot Applicable2023-01-30
00840155414020MedSource Winged CathetersMS-84216WNot Applicable2023-01-30
00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
00816703023129Elite CPR Face ShieldELITE-21105Not Applicable2021-04-20
00816703023143Elite CPR Face ShieldELITE-21106Not Applicable2021-04-20

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