Adult & Child Silicone Masks w/ Multi-Func Mask Covers 872220

GUDID 07045430012646

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
Primary Device ID07045430012646
NIH Device Record Key6d8a5326-8b77-4c33-bbb0-74f1b02d3b31
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult & Child Silicone Masks w/ Multi-Func Mask Covers
Version Model Number872220
Catalog Number872220
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107045430012646 [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

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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