Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M0665U

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042683,K042683,K042683

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

ad74edf3-b42b-4821-95af-bfe2aabd3696

Public Version Date

July 09, 2020

Public Version Number

7

DI Record Publish Date

August 26, 2016

Package DI Number

10897392004115

Quantity per Package

10

Contains DI Package

00897392001629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box