Keyring 1pkg (10pcs) UDI for Foil Pack 6900 20-09500

GUDID 07045432068665

The Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in

Laerdal Medical AS

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 07045432068665
• NIH Device Record Key: ef962d74-5e28-490c-a57e-0232a035a5cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Keyring 1pkg (10pcs) UDI for Foil Pack 6900
• Version Model Number: 20-09500
• Catalog Number: 20-09500
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)4311055
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045430009257 [Package]; Package: Carton [50 Units]; In Commercial Distribution
GS1	07045432068641 [Unit of Use]
GS1	07045432068665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880450

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-19

Devices Manufactured by Laerdal Medical AS

• 07045432120462 - Laerdal Silicone Masks: 2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
• 07045432120479 - Laerdal Silicone Masks: 2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
• 07045432120486 - Laerdal Silicone Masks: 2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
• 07045432120493 - Laerdal Silicone Masks: 2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
• 07045432120509 - Laerdal Silicone Masks: 2026-02-06 Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
• 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