Catalog Number

-

Brand Name

Mediplus

Version/Model Number

2271

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2021

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

bd135f6e-aa9d-4a49-aef4-2f02d3c1cd52

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

15055140700503

Quantity per Package

5

Contains DI Package

05055140700506

Package Discontinue Date

January 04, 2021

Package Status

Not in Commercial Distribution

Package Type

-