Catalog Number

ASK-04001-KB

Brand Name

ARROW

Version/Model Number

IPN925295

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

-

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

f70c1ec7-838a-40e8-8e23-780071941b3b

Public Version Date

July 19, 2022

Public Version Number

1

DI Record Publish Date

July 11, 2022

Package DI Number

20801902211525

Quantity per Package

5

Contains DI Package

10801902211528

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case