Catalog Number

0124-24

Brand Name

Halyard

Version/Model Number

94939

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

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

K982894,K982894

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

41042972-43d0-428c-b75f-1c9e1b06db31

Public Version Date

April 20, 2020

Public Version Number

6

DI Record Publish Date

March 15, 2017

Package DI Number

30680651949395

Quantity per Package

5

Contains DI Package

10680651949391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-