Keyring w/LFS x 25 (US) Blue 46991101

GUDID 07045431500210

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: 07045431500210
• NIH Device Record Key: b4658abe-7307-4fb2-80e5-2fb0f54d73d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Keyring w/LFS x 25 (US) Blue
• Version Model Number: 46991101
• Catalog Number: 46991101
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 25
• 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: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• 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 52 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 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	07045431500210 [Primary]
GS1	07045432068641 [Unit of Use]

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: 2015-10-20

Devices Manufactured by Laerdal Medical AS

• 07045432101676 - McKesson CPR Mask, Barrier Dev. 73508: 2023-02-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant.
• 07045432112269 - Newborn Mask - Size 0 Qty 1 - Snap Design: 2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615601, LGH-84615601
• 07045432112399 - Newborn Mask - Size 1 Qty 1 - Snap Design (US): 2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701
• 07045432101690 - McKesson CPR Mask, Barrier Dev. w/O2 73509: 2021-12-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.
• 07045430041257 - Laerdal Thomas Tube Holder Adult: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045430041264 - Laerdal Thomas Tube Holder Pedi: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045430041271 - Laerdal Thomas Tube Holder Adult (Green): 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045432072310 - Laerdal Thomas Select Tube Holder, Adult: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert