Catalog Number

UC-19612-KJU

Brand Name

ARROW

Version/Model Number

IPN048794

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

K162522,K162522

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

41dc8874-e4fa-4a9b-b254-019aadc63528

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

November 09, 2018

Package DI Number

40801902134538

Quantity per Package

5

Contains DI Package

30801902134531

Package Discontinue Date

April 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Case