Catalog Number

AB-00050

Brand Name

ARROW

Version/Model Number

IPN040001

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

168a44cd-3570-4ac3-800a-06e869562636

Public Version Date

February 27, 2020

Public Version Number

6

DI Record Publish Date

December 22, 2016

Package DI Number

50801902028360

Quantity per Package

1

Contains DI Package

20801902028369

Package Discontinue Date

February 24, 2020

Package Status

Not in Commercial Distribution

Package Type

Case