Catalog Number

-

Brand Name

LEAK TEST AIR TUBE

Version/Model Number

MAJ-2127

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190969

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Public Device Record Key

6a31913a-edd1-4b51-8a79-d555269ad2d1

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-