Catalog Number

-

Brand Name

andorate® Air/Water Bottle Tubing

Version/Model Number

GAR025US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 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"

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

8e1984f0-1ab2-430b-b3df-035de0943481

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 28, 2020

Package DI Number

14897106950024

Quantity per Package

10

Contains DI Package

04897106950027

Package Discontinue Date

November 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Box