Catalog Number

ETRC755

Brand Name

Endure

Version/Model Number

ETRC7551217

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K140228,K140228,K140228

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

b7878896-035b-4804-9410-14da2b5b704a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 21, 2018

Package DI Number

B531ETRC7552

Quantity per Package

10

Contains DI Package

B531ETRC7551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton