Paediatric Pocket Mask CPR Barrier Device 820050

GUDID 07045430011557

The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant.

Laerdal Medical AS

Cardiopulmonary resuscitation mask, single-use
Primary Device ID07045430011557
NIH Device Record Keycaeac4ff-246f-45d8-86b0-1ce032d6de28
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaediatric Pocket Mask CPR Barrier Device
Version Model Number820050
Catalog Number820050
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 Usetrue
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 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107045430011557 [Primary]
GS107045432068474 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-19

Devices Manufactured by Laerdal Medical AS

07045432101676 - McKesson CPR Mask, Barrier Dev. 735082023-02-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant.
07045432112269 - Newborn Mask - Size 0 Qty 1 - Snap Design2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615601, LGH-84615601
07045432112399 - Newborn Mask - Size 1 Qty 1 - Snap Design (US)2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701
07045432101690 - McKesson CPR Mask, Barrier Dev. w/O2 735092021-12-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.
07045430041257 - Laerdal Thomas Tube Holder Adult2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
07045430041264 - Laerdal Thomas Tube Holder Pedi2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
07045430041271 - Laerdal Thomas Tube Holder Adult (Green)2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
07045432072310 - Laerdal Thomas Select Tube Holder, Adult2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert

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