FDA.reportPublic FDA data

N/A

Primary DI
10607411300698
Brand
N/A
Company
SALTER LABS
Model
M125335-0
Catalog number
M125335-0
Device description
Oxygen Mask (Adult) Medium Concentration Elastic Strap fixation
Published
2016-12-16
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

Contact Domains#

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
10607411300698PackageGS150In Commercial Distribution
00607411300691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741130069810607411300698
00607411300691006074113006916074113006910607411300691

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
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
00607411966378IntuBrite SterileS01-6015.CS01-6015.C2018-12-13
00607411966385IntuBrite SterileS01-6016.CS01-6016.C2018-12-13
00607411966392IntuBrite SterileS01-6017.CS01-6017.C2018-12-13
00607411973055AirLifeSO-2169-0SO-2169-02026-05-11
00607411973062AirLifeSO-2170-0SO-2170-02026-05-11
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
00607411200915N/AL7600-0L7600-02016-09-24
00607411300738AirLifeSO-1500-0SO-1500-02016-11-30
00607411889097AirLifeSO-1188-0SO-1188-02016-11-30
00607411889103AirLifeSO-1189-0SO-1189-02016-11-30
00607411889110AirLifeSO-1190-0SO-1190-02016-11-30
00607411918025AirLifeSO-1968-0SO-1968-02016-11-30
00607411918070AirLifeSO-1972-0SO-1972-02016-11-30
00607411102035Salter Labs8107V-02026-04-24
00607411800870N/A1107-01107-02016-11-30
00607411001017N/A1003-0-501003-0-502016-12-16
10607411976237NebuTech8990TG-7-508990TG-7-502023-09-25
10607411001229Salter AIRE Elite8501-0-58501-0-52018-02-09
00607411001611N/ASO-461SO-4612016-09-24
00607411102103Salter AIRE Elite8352-8924-7-18352-8924-7-12016-09-24

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