Catalog Number

ASK-05052-DMI

Brand Name

ARROW

Version/Model Number

IPN037285

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

K003006,K003006

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Public Device Record Key

8ab5240e-63d1-4f93-96ef-13294d52c279

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 30, 2016

Package DI Number

20801902113386

Quantity per Package

5

Contains DI Package

10801902113389

Package Discontinue Date

September 05, 2018

Package Status

Not in Commercial Distribution

Package Type

Case