Catalog Number

AK-05503-L

Brand Name

ARROW

Version/Model Number

IPN045609

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

b8f13e98-31ac-45c8-af51-e670672074c0

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

July 17, 2018

Package DI Number

40801902005159

Quantity per Package

10

Contains DI Package

50801902005156

Package Discontinue Date

September 24, 2018

Package Status

Not in Commercial Distribution

Package Type

Box