Keyring w/LFS x 25 (US) Yellow 46990801

GUDID 07045431500197

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 ID07045431500197
NIH Device Record Key8dbc058c-9eec-4747-867c-d174f4dca71c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKeyring w/LFS x 25 (US) Yellow
Version Model Number46990801
Catalog Number46990801
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(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
Emailcustomerservice@laerdal.com
Phone(877) 523-7325
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
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
GS107045431500197 [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 Date2015-10-20

Devices Manufactured by Laerdal Medical AS

07045432119251 - Pocket Mask O2, PB (DE FR ES IT EN)2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119268 - Pocket Mask O2, SP Blue (DE FR ES IT EN)2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119275 - Pocket Mask O2,HC Yellow (DE FR ES IT EN)2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119299 - Pocket Mask O2, HC White Private Label2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119312 - Pocket Mask O2, SP Black Private Label2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119336 - Pocket Mask O2, SP Camo Private Label2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119879 - Pocket Mask O2,HC Yellow (EN)2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re
07045432119947 - Pocket Mask O2, PB (EN)2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re

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