Catalog Number

ASK-41541-SH1

Brand Name

ARROW

Version/Model Number

IPN914812

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

K161313,K161313

Product Code

PND

Product Code Name

Midline catheter

Public Device Record Key

8015cc15-d977-4ea1-8430-d429698c8228

Public Version Date

May 01, 2020

Public Version Number

3

DI Record Publish Date

July 25, 2019

Package DI Number

20801902158158

Quantity per Package

5

Contains DI Package

10801902158151

Package Discontinue Date

April 29, 2020

Package Status

Not in Commercial Distribution

Package Type

Case