Catalog Number

97014

Brand Name

AVANOS

Version/Model Number

13903

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

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

9933ff06-e10f-4072-a3c0-19402192197f

Public Version Date

July 10, 2020

Public Version Number

1

DI Record Publish Date

July 02, 2020

Package DI Number

10609038139033

Quantity per Package

16

Contains DI Package

00609038139036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS