Catalog Number

-

Brand Name

andorate® Air/Water Bottle Tubing

Version/Model Number

GAR090US

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"

-

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

a8bd3a82-baac-41d1-a367-48d569ccf95e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 23, 2022

Package DI Number

14897106954978

Quantity per Package

20

Contains DI Package

04897106954971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box