Catalog Number

0143-24-200

Brand Name

Halyard

Version/Model Number

46965

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993138,K993138,K993138

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

b5424ef8-3373-4b64-b5e2-75227debc30b

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

March 22, 2018

Package DI Number

30680651469657

Quantity per Package

50

Contains DI Package

20680651469650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS