Catalog Number

97014

Brand Name

Halyard

Version/Model Number

13903

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

-

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

be236a76-329b-4617-bece-1e7e9c969d57

Public Version Date

November 16, 2018

Public Version Number

3

DI Record Publish Date

May 11, 2017

Package DI Number

30680651139031

Quantity per Package

16

Contains DI Package

20680651139034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cs