Catalog Number

0321-24

Brand Name

AVANOS

Version/Model Number

98714

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

KNT

Product Code Name

Tubes, gastrointestinal (and accessories)

Public Device Record Key

8d09cb62-3a47-410e-8b60-1698089a59de

Public Version Date

May 05, 2020

Public Version Number

1

DI Record Publish Date

April 27, 2020

Package DI Number

10350770987146

Quantity per Package

5

Contains DI Package

00350770987149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS