Catalog Number

-

Brand Name

n/a

Version/Model Number

7179-0035

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,K954798

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, And Tube

Public Device Record Key

7e94fd05-a85f-4e1a-b7bc-3a4464a60f6c

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

April 05, 2017

Package DI Number

34961333230458

Quantity per Package

25

Contains DI Package

04961333230457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG