Catalog Number

-

Brand Name

Mui Scientific

Version/Model Number

CE4-1319

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K983665

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Public Device Record Key

10044208-4bea-4595-a2c0-fb6734e958c1

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

February 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-