Catalog Number

AI-07127-STC

Brand Name

ARROW

Version/Model Number

IPN917228

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

K892530,K892530

Product Code

DYG

Product Code Name

CATHETER, FLOW DIRECTED

Public Device Record Key

5b4418b2-9e39-4b72-bea9-75153943ba44

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Package DI Number

20801902180340

Quantity per Package

5

Contains DI Package

10801902180343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case