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

Primary Device ID	07045432066333
NIH Device Record Key	85cf369d-29c2-4774-a20d-2917eb87e002
Commercial Distribution Status	In Commercial Distribution
Brand Name	NeoNatalie Resuscitator (US)
Version Model Number	84604001
Catalog Number	84604001
Company DUNS	730624095
Company Name	Laerdal Medical AS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com
Phone	(800)431-1055
Email	customerservice@laerdal.com

Operating and Storage Conditions

Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 5 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	07045432066333 [Primary]
GS1	07045432067675 [Package] Package: Carton [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132172

FDA Product Code

BTM	Ventilator, Emergency, Manual (Resuscitator)