DEVICE: LCSU 4, 300 ml, RTCA Complete unit (EUR) (07045432048124)

Device Identifier (DI) Information

LCSU 4, 300 ml, RTCA Complete unit (EUR)
88006240
In Commercial Distribution
88006240
Laerdal Medical AS
07045432048124
GS1

1
730624095 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Emergency airway clearance suction system, electric A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.
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FDA Product Code

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Product Code Product Code Name
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f0cf97fc-1153-4976-8d16-3e28b1b21772
August 23, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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(800)4311055
customerservice@laerdal.com
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