Catalog Number

AI-07365-NHL

Brand Name

ARROW

Version/Model Number

IPN917256

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)

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

-

Product Code

DYG

Product Code Name

CATHETER, FLOW DIRECTED

Public Device Record Key

7aae48af-ddaf-4130-a2a7-0f89492e939f

Public Version Date

August 25, 2021

Public Version Number

1

DI Record Publish Date

August 17, 2021

Package DI Number

20801902181026

Quantity per Package

5

Contains DI Package

10801902181029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case