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

7a33046b-95e2-463b-b37d-8b22671a6878

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 11, 2018

Package DI Number

60801902113384

Quantity per Package

5

Contains DI Package

70801902113381

Package Discontinue Date

April 09, 2020

Package Status

Not in Commercial Distribution

Package Type

Case