Catalog Number

EC-05400-E

Brand Name

ARROW

Version/Model Number

IPN046378

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

53335e42-f536-4780-8ef9-1b5c4ab97d4e

Public Version Date

April 15, 2020

Public Version Number

6

DI Record Publish Date

May 17, 2018

Package DI Number

30801902128400

Quantity per Package

20

Contains DI Package

40801902128407

Package Discontinue Date

April 08, 2020

Package Status

Not in Commercial Distribution

Package Type

Case