Catalog Number

-

Brand Name

EsoFLIP

Version/Model Number

ES-330

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

K132337,K132337

Product Code

PID

Product Code Name

Esophageal Dilator Balloon With Or Without Electrode Sensors

Public Device Record Key

6f9e84bf-0dc1-4844-8dc9-7039110a7399

Public Version Date

April 29, 2020

Public Version Number

4

DI Record Publish Date

August 02, 2016

Package DI Number

05391530810098

Quantity per Package

5

Contains DI Package

05391530810043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box