Catalog Number

AH-05050-G

Brand Name

ARROW

Version/Model Number

IPN000032

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K895268,K895268

Product Code

DYG

Product Code Name

CATHETER, FLOW DIRECTED

Public Device Record Key

12e1a41c-5e5f-42b3-a4e2-99406bb1ded9

Public Version Date

August 12, 2022

Public Version Number

10

DI Record Publish Date

September 16, 2016

Package DI Number

30801902003998

Quantity per Package

5

Contains DI Package

00801902003997

Package Discontinue Date

August 11, 2022

Package Status

Not in Commercial Distribution

Package Type

Case