The BAG Manometer 8470401

GUDID 07045432116144

The BAG Manometer is a non-sterile single use accessory for displaying the airway pressure use with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.

Laerdal Medical AS

Airway pressure monitor, non-powered

• Primary Device ID: 07045432116144
• NIH Device Record Key: 4ac691a2-1cbc-49da-9e38-c068aeb6a2dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The BAG Manometer
• Version Model Number: 8470401
• Catalog Number: 8470401
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432116144 [Package]; Contains: 07045432116151; Package: Carton [12 Units]; In Commercial Distribution
GS1	07045432116151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251631

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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

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• 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: 2026-01-22 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