Catalog Number

-

Brand Name

Andorate® Air/Water Channel Cleaning Adapter

Version/Model Number

GAR038

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

Yes

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

FFY

Product Code Name

Adaptor, Bulbs, Miscellaneous, For Endoscope

Public Device Record Key

cb2d694c-28ff-4d39-94c2-7f802f64db91

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 07, 2020

Package DI Number

14897106950468

Quantity per Package

100

Contains DI Package

04897106950461

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box