Catalog Number

EDB-250

Brand Name

AVANOS

Version/Model Number

46915

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

FFD

Product Code Name

EVACUATOR, BLADDER, MANUALLY OPERATED

Public Device Record Key

b6a54628-29ab-4d9c-8c51-c10531a8c2d7

Public Version Date

April 03, 2020

Public Version Number

2

DI Record Publish Date

February 17, 2020

Package DI Number

10350770469154

Quantity per Package

30

Contains DI Package

00350770469157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS