Keyring w/LFS x 25 Camouflage 460017

GUDID 07045430040502

The Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in

Laerdal Medical AS

Cardiopulmonary resuscitation mask, single-use
Primary Device ID07045430040502
NIH Device Record Key1472b4e3-6d1d-483a-9d8e-5f8e97aeb728
Commercial Distribution StatusIn Commercial Distribution
Brand NameKeyring w/LFS x 25 Camouflage
Version Model Number460017
Catalog Number460017
Company DUNS730624095
Company NameLaerdal Medical AS
Device Count25
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
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
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 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107045430040502 [Primary]
GS107045432068641 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

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

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07045432118308 - NeoBeat Mini Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432118322 - NeoBeat Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432118339 - NeoBeat Mini Sys Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
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.

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