Catalog Number

Li11177

Brand Name

LiDCO

Version/Model Number

Li11177

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 20, 2018

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

K152935

Product Code

DXG

Product Code Name

COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Public Device Record Key

b8faa40a-5dae-4c38-a335-555a2c38d478

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

May 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-