Adult & Child Silicone Masks w/ Multi-Func Mask Covers 872220

GUDID 07045430012646

Laerdal Silicone Masks are intended to be used for ventilation of patients. The multi-function Mask Cover is intended to be used to add additional support, when needed, to Laerdal Silisone Masks (sizes 3-4, 4-5+) and to allow for strapping of Laerdal Silicone Masks to the patient.

Laerdal Medical AS

Resuscitator face mask, reusable

• Primary Device ID: 07045430012646
• NIH Device Record Key: 6d8a5326-8b77-4c33-bbb0-74f1b02d3b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult & Child Silicone Masks w/ Multi-Func Mask Covers
• Version Model Number: 872220
• Catalog Number: 872220
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045430012646 [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: 2020-11-05
• Device Publish Date: 2020-10-28

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