Pocket Mask,SP (Blue,IE) 82004033

GUDID 07045430043824

The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant.

Laerdal Medical AS

Cardiopulmonary resuscitation mask, reusable
Primary Device ID07045430043824
NIH Device Record Key1523e2ba-2ffb-4dd5-9003-b7551bf484f4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePocket Mask,SP (Blue,IE)
Version Model Number82004033
Catalog Number82004033
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800)4311055
Emailcustomerservice@laerdal.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107045430043824 [Primary]
GS107045432068245 [Package]
Package: Carton [100 Units]
In Commercial Distribution

FDA Product Code

CBPValve, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-20

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