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 ID: 07045430042087
• NIH Device Record Key: 456a010f-7d08-4521-abdb-a7cbf00e6a02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LSU w/Reusable Canister, Canadian French
• Version Model Number: 78000016
• Catalog Number: 78000016
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com
• Phone: (877) 523-7325
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury
• Storage Environment Temperature: Between 0 Millimeter of Mercury and 40 Millimeter of Mercury
• Storage Environment Humidity: Between 0 Inches of Mercury and 95 Inches of Mercury

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045430042087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993668

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-26

Devices Manufactured by Laerdal Medical AS

• 07045432101676 - McKesson CPR Mask, Barrier Dev. 73508: 2023-02-14 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 Design: 2022-12-08 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 73509: 2021-12-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.
• 07045430041257 - Laerdal Thomas Tube Holder Adult: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045430041264 - Laerdal Thomas Tube Holder Pedi: 2021-10-28 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, Adult: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert