Catalog Number

-

Brand Name

SourceMark

Version/Model Number

MX0475C

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

1584c086-0c3d-4318-b4ec-b49de2a02513

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Package DI Number

10813799004657

Quantity per Package

10

Contains DI Package

00813799004643

Package Discontinue Date

July 08, 2020

Package Status

Not in Commercial Distribution

Package Type

Box