Catalog Number

7020-1468

Brand Name

mPower Cath™

Version/Model Number

7020-1468

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

-

Product Code

EZD

Product Code Name

Catheter, Straight

Public Device Record Key

30a81647-851e-42e7-97b0-8df994f1fb84

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 27, 2016

Package DI Number

00851847007048

Quantity per Package

100

Contains DI Package

00851847007031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 100 units