Catalog Number

-

Brand Name

Eswallow

Version/Model Number

ESW-9030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2017

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

5067c5c9-fe36-4c5e-9809-fb6ac99c57bb

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

80092237618253

Quantity per Package

8

Contains DI Package

00092237618257

Package Discontinue Date

June 30, 2017

Package Status

Not in Commercial Distribution

Package Type

CA