Catalog Number

M118080

Brand Name

PowerGlide Midline Catheter

Version/Model Number

M118080

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

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

848a2578-7a77-4c05-8546-19eb7fb54043

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 17, 2016

Package DI Number

20801741038086

Quantity per Package

2

Contains DI Package

10801741038089

Package Discontinue Date

August 31, 2014

Package Status

Not in Commercial Distribution

Package Type

CA