Catalog Number

97012

Brand Name

AVANOS

Version/Model Number

13904

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

c5de3e11-4cfe-4d78-b340-fcffd4e48348

Public Version Date

July 10, 2020

Public Version Number

1

DI Record Publish Date

July 02, 2020

Package DI Number

10609038139040

Quantity per Package

7

Contains DI Package

00609038139043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS