Catalog Number

-

Brand Name

Halyard

Version/Model Number

35115

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

171652ae-1aea-4f21-a42e-baecc34de332

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2015

Package DI Number

30680651351150

Quantity per Package

10

Contains DI Package

10680651351156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-