Catalog Number

K194AC-L-1502

Brand Name

Latitude Catheter

Version/Model Number

GIM6000D00

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

-

Product Code

KLA

Product Code Name

MONITOR, ESOPHAGEAL MOTILITY, AND TUBE

Public Device Record Key

1e05a1b3-7a52-4f95-abb1-12afbb5c37da

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

07640172972557

Quantity per Package

4

Contains DI Package

07640172972540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-