Catalog Number

Li11150

Brand Name

LiDCO Ltd

Version/Model Number

Li11150

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 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

72e7b91e-521e-4673-baf3-0cf80a5d432f

Public Version Date

November 10, 2021

Public Version Number

8

DI Record Publish Date

November 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-