Catalog Number

4434447-02

Brand Name

EASYPUMP

Version/Model Number

4434447-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

d00c454d-52b4-4d87-9ffa-6af159be8075

Public Version Date

April 21, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-