Catalog Number

-

Brand Name

andorate® Air/Water Bottle Tubing

Version/Model Number

GAR088US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 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"

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

1eab66f1-b1ee-4c90-ade3-742f5b9aadb1

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 28, 2020

Package DI Number

14897106950123

Quantity per Package

10

Contains DI Package

04897106950126

Package Discontinue Date

October 16, 2020

Package Status

Not in Commercial Distribution

Package Type

Box