LSU w/Reusable Canister, Canadian French 78000016

GUDID 07045430042087

The LSU is a portable, electrically powered, medical suction equipment intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient´s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suctioning, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.

Laerdal Medical AS

Emergency airway clearance suction system, electric
Primary Device ID07045430042087
NIH Device Record Key456a010f-7d08-4521-abdb-a7cbf00e6a02
Commercial Distribution StatusIn Commercial Distribution
Brand NameLSU w/Reusable Canister, Canadian French
Version Model Number78000016
Catalog Number78000016
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
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 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury
Storage Environment TemperatureBetween 0 Millimeter of Mercury and 40 Millimeter of Mercury
Storage Environment HumidityBetween 0 Inches of Mercury and 95 Inches of Mercury

Device Identifiers

Device Issuing AgencyDevice ID
GS107045430042087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-03
Device Publish Date2019-03-26

Devices Manufactured by Laerdal Medical AS

07045432115987 - The BAG Mask size 12026-01-22 The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a
07045432115994 - The BAG Mask size 2 2026-01-22 The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a
07045432116007 - The BAG Mask size 3 2026-01-22 The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a
07045432116014 - The BAG Mask size 42026-01-22 The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a
07045432116021 - The BAG Mask size 52026-01-22 The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a
07045432116083 - The BAG PEEP Valve 2-10 cmH2O2026-01-22 The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with La
07045432116090 - The BAG PEEP Valve 5-20 cmH2O2026-01-22 The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with La
07045432116144 - The BAG Manometer2026-01-22 The BAG Manometer is a non-sterile single use accessory for displaying the airway pressure use with Laerdal The BAG resuscitator

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