Catalog Number

-

Brand Name

Gasjet CO2 Delivery System

Version/Model Number

EGA-501T

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

-

Product Code

FCX

Product Code Name

Insufflator, Automatic Carbon-Dioxide For Endoscope

Public Device Record Key

a635050c-9f30-4906-a3f1-597da6bc9600

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

May 04, 2017

Package DI Number

30677964085575

Quantity per Package

1

Contains DI Package

00677964085574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-