Catalog Number

5-13016

Brand Name

TELEFLEX

Version/Model Number

IPN044813

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

db8214ca-20cc-455f-82df-18cea760ffb4

Public Version Date

October 04, 2019

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

24026704588361

Quantity per Package

10

Contains DI Package

04026704588367

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box