DEVICE: LCSU 4, 300 ml, Complete Unit (US) (07045432046632)
Device Identifier (DI) Information
LCSU 4, 300 ml, Complete Unit (US)
88006101
In Commercial Distribution
88006101
Laerdal Medical AS
88006101
In Commercial Distribution
88006101
Laerdal Medical AS
The LCSU 4 is a portable, electrically powered, medical suction device 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 suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Airway emergency clearance/suction system, electric | A portable assembly of devices primarily intended to be used by emergency medical services (EMS) to aspirate fluids, secretions, or other foreign materials from a patient's airway by means of suction. It typically consists of a battery-powered mechanism to drive the suction pump, tubing, a collection container, a vacuum gauge and control knob, internal rechargeable batteries and a microbial filter. The pump creates a vacuum in the suction tubing, which is used for the removal of materials into the collection container. This system is typically used during patient transport or for emergency situations (e.g., placed on a crash cart) or by a homecare patient that requires “portable” suction. |
FDA Product Code
[?]Product Code | Product Code Name |
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JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4a141ef5-0626-4f6d-b9a4-df7c3240c85b
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(800)4311055
customerservice@laerdal.com
customerservice@laerdal.com