Catalog Number

JC-05400-E

Brand Name

ARROW

Version/Model Number

IPN040162

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K103658,K103658

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

411956e8-a5c6-4176-8243-b7c5e9cc7a75

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

July 20, 2017

Package DI Number

10801902011289

Quantity per Package

20

Contains DI Package

20801902011286

Package Discontinue Date

February 28, 2018

Package Status

Not in Commercial Distribution

Package Type

Box