Catalog Number

-

Brand Name

EcoFLX™

Version/Model Number

DPT1130

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

K915560,K915560

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

0bd6eedd-7a93-4a50-8509-00be7101e335

Public Version Date

February 25, 2019

Public Version Number

1

DI Record Publish Date

January 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-