Catalog Number

0034830

Brand Name

Evacuator

Version/Model Number

0034830

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Public Device Record Key

461052d6-02fb-42f0-8246-ac9d387b9df6

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

20801741049235

Quantity per Package

2

Contains DI Package

10801741049238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA