Catalog Number

Not a catalog item

Brand Name

LiDCO Ltd

Version/Model Number

Li10955

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

Yes

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

K131048,K131048

Product Code

DXG

Product Code Name

COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Public Device Record Key

59c65ceb-01b6-4615-902f-7ca68007d8aa

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

September 13, 2016

Package DI Number

15060110522078

Quantity per Package

5

Contains DI Package

05060110522071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-