Catalog Number

-

Brand Name

N/A

Version/Model Number

7182-2300

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

K954798

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, And Tube

Public Device Record Key

cbf25b98-9eaf-4021-bcb9-dcd66cf18711

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

March 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-