FDA.reportPublic FDA data

The BAG Mask size 1

Primary DI
07045432116038
Brand
The BAG Mask size 1
Company
Laerdal Medical AS
Model
8470111
Catalog number
8470111
Device description
The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
07045432115987PackageGS112In Commercial Distribution
07045432116038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07045432115987070454321159877045432115987
07045432116038070454321160387045432116038

GMDN Terms#

Term, Definition table
TermDefinition
Resuscitator face mask, single-useA non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
730624095
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07045432119350The BAG™ Resuscitator - Newborn model847110401 2026-03-30
07045432119398The BAG™ Resuscitator - Pediatric model8472304012026-03-30
07045432119411The BAG™ Resuscitator - Adult model847340401 2026-03-30
07045432119503The BAG™ Resuscitator - Adult model847350401 2026-03-30
07045432119534The BAG™ Resuscitator - Pediatric model847220401 2026-03-30
07045432120462Laerdal Silicone Masks851500-12026-01-29
07045432120479Laerdal Silicone Masks851600-12026-01-29
07045432120486Laerdal Silicone Masks851700-1 2026-01-29
07045432120493Laerdal Silicone Masks860220-12026-01-29
07045432120509Laerdal Silicone Masks870220-12026-01-29
07045432116045The BAG Mask size 2 847012184701212026-01-14
07045432116052The BAG Mask size 3 8470128470122026-01-14
07045432116069The BAG Mask size 484701412026-01-14
07045432116076The BAG Mask size 5847015184701512026-01-14
07045432116106The BAG PEEP Valve 2-10 cmH2O847021184702112026-01-14
07045432116113The BAG PEEP Valve 5-20 cmH2O8470211 8470211 2026-01-14
07045432116151The BAG Manometer8470401 8470401 2026-01-14
07045432115987The BAG Mask size 18470111 8470111 2026-01-14
07045432115994The BAG Mask size 2 847012184701212026-01-14
07045432116007The BAG Mask size 3 8470128470122026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06