Catalog Number

M122081D

Brand Name

PowerGlide Midline Catheter

Version/Model Number

M122081D

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

5214d58f-6f97-4bcb-a820-8ffe45f2acf2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 17, 2016

Package DI Number

10801741038164

Quantity per Package

5

Contains DI Package

00801741038167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA