Catalog Number

-

Brand Name

andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit

Version/Model Number

GAR105092

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

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

a3182b1a-18f3-40e9-890a-57dd67bfe674

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Package DI Number

14897106954084

Quantity per Package

10

Contains DI Package

04897106954087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box