LCSU 4, 300 ml, Complete Unit 880061

GUDID 07045432067040

The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation

Laerdal Medical AS

Emergency airway clearance suction system, electric

• Primary Device ID: 07045432067040
• NIH Device Record Key: d26e2b2c-67c6-4b61-9093-8bf461a96bdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LCSU 4, 300 ml, Complete Unit
• Version Model Number: 880061
• Catalog Number: 880061
• 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: true
• 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: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432067040 [Direct Marking]
GS1	07045432088489 [Primary]
GS1	07045432088526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120065

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-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: 2019-02-04
• Device Publish Date: 2019-01-02

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