Catalog Number

AK-05500

Brand Name

ARROW

Version/Model Number

IPN038354

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

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

e71bdc92-4663-4bec-9d3c-f85150eda7a7

Public Version Date

November 08, 2019

Public Version Number

9

DI Record Publish Date

February 08, 2018

Package DI Number

40801902138994

Quantity per Package

10

Contains DI Package

30801902138997

Package Discontinue Date

October 30, 2018

Package Status

Not in Commercial Distribution

Package Type

Case