Catalog Number

CDC-02051-MK1A

Brand Name

ARROW

Version/Model Number

IPN036418

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

K963257,K963257

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

5a255e93-916c-483a-b6a5-abab7b077991

Public Version Date

November 05, 2018

Public Version Number

4

DI Record Publish Date

September 08, 2017

Package DI Number

30801902123351

Quantity per Package

5

Contains DI Package

20801902123354

Package Discontinue Date

October 25, 2018

Package Status

Not in Commercial Distribution

Package Type

Case