Catalog Number

8180-14

Brand Name

Halyard

Version/Model Number

44611

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

K924065,K924065

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

befece1e-e0a9-4cbb-8b9e-24e27bb91e51

Public Version Date

April 20, 2020

Public Version Number

6

DI Record Publish Date

August 22, 2016

Package DI Number

30680651446115

Quantity per Package

2

Contains DI Package

10680651446111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS