Catalog Number

ASK-04001-TCH

Brand Name

ARROW

Version/Model Number

IPN921047

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

-

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

c92d8bf4-5043-4fa5-b4d1-6c1053754db4

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

April 01, 2022

Package DI Number

40801902199322

Quantity per Package

5

Contains DI Package

30801902199325

Package Discontinue Date

June 13, 2022

Package Status

Not in Commercial Distribution

Package Type

Case