Catalog Number

43-4100

Brand Name

AVANOS

Version/Model Number

43-4100

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

-

Product Code

PIF

Product Code Name

Gastrointestinal Tubes with Enteral Specific Connectors

Public Device Record Key

8da1a656-4703-4f72-abd7-9d2fc05766ab

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

10350770461011

Quantity per Package

30

Contains DI Package

00350770461014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS