LSR Silicone Mask No.2 851700

GUDID 07045430012271

Laerdal Silicone Masks are intended to be used for ventilation of patients. The multi-function Mask Cover is intended to be used to add additional support, when needed, to Laerdal Silisone Masks (sizes 3-4, 4-5+) and to allow for strapping of Laerdal Silicone Masks to the patient.

Laerdal Medical AS

Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable Resuscitator face mask, reusable
Primary Device ID07045430012271
NIH Device Record Key3152e1b0-2a8b-44f8-987b-0dce9b8ec7ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameLSR Silicone Mask No.2
Version Model Number851700
Catalog Number851700
Company DUNS730624095
Company NameLaerdal Medical AS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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
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
Phone(800)4311055
Emailcustomerservice@laerdal.com

Operating and Storage Conditions

Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 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
GS107045430012271 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-05
Device Publish Date2020-10-28

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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