Catalog Number

-

Brand Name

andorate® Air/Water Bottle Tubing with CO2 Extend

Version/Model Number

GAR072CO2EXTUS

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"

Yes

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

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

21850bd3-4384-4690-815e-9030ea9228cc

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

May 28, 2020

Package DI Number

14897106950086

Quantity per Package

10

Contains DI Package

04897106950089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box