Newborn Mask - Size 1 Qty 10 - Snap Design (US) 84615701

GUDID 07045432087345

Newborn Masks are intended for face mask ventilation of newborns and infants.

Laerdal Medical AS

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Primary Device ID	07045432087345
NIH Device Record Key	d2d697a1-1ffe-4f38-93c0-41b8cabcc470
Commercial Distribution Status	In Commercial Distribution
Brand Name	Newborn Mask - Size 1 Qty 10 - Snap Design (US)
Version Model Number	84615701
Catalog Number	84615701
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 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432087345 [Primary]

FDA Product Code

BYG	Mask, Oxygen