The BAG Mask size 3 847012

GUDID 07045432116007

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 ID: 07045432116007
• NIH Device Record Key: 82b45e82-f93d-4e10-8562-c3c1ecd70d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The BAG Mask size 3
• Version Model Number: 847012
• Catalog Number: 847012
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432116007 [Package]; Contains: 07045432116052; Package: Carton [12 Units]; In Commercial Distribution
GS1	07045432116052 [Primary]

FDA Product Code

• BYG: Mask, Oxygen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by Laerdal Medical AS

• 07045432115987 - The BAG Mask size 1: 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
• 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: 2026-01-22The 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
• 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
• 07045432116014 - The BAG Mask size 4: 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
• 07045432116021 - The BAG Mask size 5: 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
• 07045432116083 - The BAG PEEP Valve 2-10 cmH2O: 2026-01-22 The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with La
• 07045432116090 - The BAG PEEP Valve 5-20 cmH2O: 2026-01-22 The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with La
• 07045432116144 - The BAG Manometer: 2026-01-22 The BAG Manometer is a non-sterile single use accessory for displaying the airway pressure use with Laerdal The BAG resuscitator