Catalog Number

AB-18080-N

Brand Name

ARROW

Version/Model Number

IPN040025

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

K121403,K121403,K121403

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

ef497283-d1ca-4e97-9534-d52342839130

Public Version Date

February 27, 2020

Public Version Number

6

DI Record Publish Date

December 22, 2016

Package DI Number

10801902031294

Quantity per Package

10

Contains DI Package

40801902031295

Package Discontinue Date

February 24, 2020

Package Status

Not in Commercial Distribution

Package Type

Box