Catalog Number

ASK-05501-SM

Brand Name

ARROW

Version/Model Number

IPN045692

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K140110,K140110

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

9712bae3-d093-4f58-8b20-a35879f015f1

Public Version Date

June 29, 2022

Public Version Number

11

DI Record Publish Date

September 16, 2016

Package DI Number

30801902045745

Quantity per Package

10

Contains DI Package

00801902045744

Package Discontinue Date

June 27, 2022

Package Status

Not in Commercial Distribution

Package Type

Box