Catalog Number

TM-05401

Brand Name

ARROW

Version/Model Number

IPN046723

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

Yes

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

878dada8-4b18-4ce8-a002-3db6e0469850

Public Version Date

August 01, 2022

Public Version Number

10

DI Record Publish Date

September 16, 2016

Package DI Number

30801902014055

Quantity per Package

5

Contains DI Package

00801902014054

Package Discontinue Date

July 29, 2022

Package Status

Not in Commercial Distribution

Package Type

Case