Catalog Number

EC-05500

Brand Name

ARROW

Version/Model Number

IPN046379

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,K103658

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

49a16361-4930-4ef1-80c5-3c50bcbc0381

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

December 22, 2016

Package DI Number

60801902128364

Quantity per Package

10

Contains DI Package

40801902128360

Package Discontinue Date

February 20, 2018

Package Status

Not in Commercial Distribution

Package Type

Box