Catalog Number

Not a catalog item

Brand Name

LiDCO

Version/Model Number

Li11191

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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,K152935

Product Code

DXG

Product Code Name

COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Public Device Record Key

a828d029-86e6-440a-b153-4a6450ca1043

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

May 23, 2018

Package DI Number

15060110522917

Quantity per Package

5

Contains DI Package

05060110522910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton