Catalog Number

-

Brand Name

andorate® CO2 Extend Tubing with Luer Connector

Version/Model Number

GAR091

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 12, 2021

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

7ce1bfa7-1126-486b-aa32-e00bdf985352

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 12, 2021

Package DI Number

14897106950208

Quantity per Package

20

Contains DI Package

04897106950201

Package Discontinue Date

March 12, 2021

Package Status

Not in Commercial Distribution

Package Type

Box