Catalog Number

-

Brand Name

ACU-EVAC

Version/Model Number

EVAC IE-1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K930043

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

3a92a839-9722-41cb-97b3-9bdae5713268

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-