Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M0560U

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

7f810ea7-5e3d-4035-8fea-e5bc55865d1f

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

September 27, 2019

Package DI Number

20897392004655

Quantity per Package

10

Contains DI Package

10897392003460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case