NeoNatalie Resuscitator (US) 84604001

GUDID 07045432066333

The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory s

Laerdal Medical AS

Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable
Primary Device ID07045432066333
NIH Device Record Key85cf369d-29c2-4774-a20d-2917eb87e002
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoNatalie Resuscitator (US)
Version Model Number84604001
Catalog Number84604001
Company DUNS730624095
Company NameLaerdal Medical AS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com
Phone(800)431-1055
Emailcustomerservice@laerdal.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107045432066333 [Primary]
GS107045432067675 [Package]
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

[07045432066333]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-22

On-Brand Devices [NeoNatalie Resuscitator (US)]

07045432066333The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and
07045432092042The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and
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