Catalog Number

710304

Brand Name

NA

Version/Model Number

710304

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2020

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

K111648,K111648

Product Code

FCX

Product Code Name

INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Public Device Record Key

bc1eecfb-ba39-4ff5-a315-dfc3dcb12e54

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 17, 2016

Package DI Number

10816765013110

Quantity per Package

24

Contains DI Package

00816765013113

Package Discontinue Date

March 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Box