Catalog Number

CK001009

Brand Name

Provena Midline

Version/Model Number

CK001009

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

PND

Product Code Name

Midline catheter

Public Device Record Key

29f3208d-c2db-4ea6-a07d-2f208029489b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 13, 2021

Package DI Number

10801741220378

Quantity per Package

3

Contains DI Package

00801741220371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA