Catalog Number

-

Brand Name

andorate® CO2 Source Tubing Adapter

Version/Model Number

GAR108

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

-

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

NKC

Product Code Name

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Public Device Record Key

37429c0c-5456-40c9-9b00-14d15572f49e

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 10, 2020

Package DI Number

14897106952745

Quantity per Package

100

Contains DI Package

04897106952748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box