Catalog Number

-

Brand Name

Mediplus

Version/Model Number

2273

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

K013704,K013704

Product Code

KLA

Product Code Name

MONITOR, ESOPHAGEAL MOTILITY, AND TUBE

Public Device Record Key

e2d89531-a3a7-4ea9-86c8-c490f678103b

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

15055140700527

Quantity per Package

5

Contains DI Package

05055140700520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-