Duns Number:730624095
Device Description: The LCSU 4 is a portable, electrically powered, medical suction device intended for field 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.
Catalog Number
88005201
Brand Name
LCSU4, RTCA 800 ml Complete unit (US)
Version/Model Number
88005201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120065
Product Code
JCX
Product Code Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Public Device Record Key
02ec561f-d96e-4b3b-9ad2-31a2e936e252
Public Version Date
October 21, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |