Catalog Number

M120101

Brand Name

PowerGlide Midline Catheter

Version/Model Number

M120101

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

Yes

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

3a654627-d25a-4704-9fc4-a16a24675e63

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 17, 2016

Package DI Number

10801741038072

Quantity per Package

10

Contains DI Package

00801741038075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA