Catalog Number

5-13018

Brand Name

TELEFLEX

Version/Model Number

IPN044815

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"

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

K091761,K091761,K091761

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

c7c31e6a-8647-44e1-a956-27770b916f51

Public Version Date

October 04, 2019

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

44026704588389

Quantity per Package

10

Contains DI Package

24026704588385

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case