The BAG Mask size 4

GUDID 07045432116014

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

Laerdal Medical AS

Resuscitator face mask, single-use
Primary Device ID07045432116014
NIH Device Record Key637f8480-fe48-4bb9-9faf-ad253513a8fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe BAG Mask size 4
Version Model Number8470141
Company DUNS730624095
Company NameLaerdal Medical AS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107045432116014 [Package]
Contains: 07045432116069
Package: Carton [12 Units]
In Commercial Distribution
GS107045432116069 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-22
Device Publish Date2026-01-14

Devices Manufactured by Laerdal Medical AS

07045432120462 - Laerdal Silicone Masks2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
07045432120479 - Laerdal Silicone Masks2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
07045432120486 - Laerdal Silicone Masks2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
07045432120493 - Laerdal Silicone Masks2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
07045432120509 - Laerdal Silicone Masks2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
07045432115987 - The BAG Mask size 12026-01-22 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
07045432115994 - The BAG Mask size 2 2026-01-22 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
07045432116007 - The BAG Mask size 3 2026-01-22 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

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.