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 ID07045432087345
NIH Device Record Keyd2d697a1-1ffe-4f38-93c0-41b8cabcc470
Commercial Distribution StatusIn Commercial Distribution
Brand NameNewborn Mask - Size 1 Qty 10 - Snap Design (US)
Version Model Number84615701
Catalog Number84615701
Company DUNS730624095
Company NameLaerdal Medical AS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com
Phone(800)4311055
Emailcustomerservice@laerdal.com

Operating and Storage Conditions

Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107045432087345 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


[07045432087345]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-05
Device Publish Date2020-10-28

On-Brand Devices [Newborn Mask - Size 1 Qty 10 - Snap Design (US)]

07045432092479Newborn Masks are intended for face mask ventilation of newborns and infants.
07045432087345Newborn Masks are intended for face mask ventilation of newborns and infants.

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