Newborn Mask - Size 0 Qty 1 - Snap Design 856156-1

GUDID 07045432112269

Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615601, LGH-84615601

Laerdal Medical AS

Resuscitator face mask, reusable
Primary Device ID07045432112269
NIH Device Record Key66b97549-c912-4515-bd0a-0958d4d3d455
Commercial Distribution StatusIn Commercial Distribution
Brand NameNewborn Mask - Size 0 Qty 1 - Snap Design
Version Model Number856156-1
Catalog Number856156-1
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107045432112269 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


[07045432112269]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

Devices Manufactured by Laerdal Medical AS

07045432118179 - Pocket Mask, PB (DE FR ES IT EN)2025-09-04 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432118285 - Pocket Mask, SP Blue (DE FR ES IT EN)2025-09-04 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432119244 - Pocket Mask, HC Yellow (DE FR ES IT EN)2025-09-04 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432118186 - Pocket Mask, PB (EN)2025-09-02 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432118230 - Pocket Mask, SP Blue (EN)2025-09-02 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432119282 - Pocket Mask, HC White Private Label2025-09-02 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432119305 - Pocket Mask, SP Black Private Label2025-09-02 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between
07045432119329 - Pocket Mask, SP Camo Private Label2025-09-02 The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between

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