Catalog Number

PP4255108DGPX

Brand Name

Midline Catheter Kit

Version/Model Number

PP4255108DGPX

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

PND

Product Code Name

Midline catheter

Public Device Record Key

538fd413-9bad-43b1-b4b1-c338f7a44907

Public Version Date

September 27, 2019

Public Version Number

1

DI Record Publish Date

September 19, 2019

Package DI Number

10801741185301

Quantity per Package

3

Contains DI Package

00801741185304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA