Catalog Number

EDS-1000

Brand Name

AVANOS

Version/Model Number

46918

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

eeb131f4-4225-41b4-9a73-02c468169d3f

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

Package DI Number

10350770469185

Quantity per Package

30

Contains DI Package

00350770469188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS