Catalog Number

-

Brand Name

EcoFLX™ Empty Mixing Container

Version/Model Number

DME2000

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"

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

K932640,K932640

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

d8feba59-62e3-4ed8-8d3b-a9ddff94c110

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

May 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-