Catalog Number

MH-05001-1

Brand Name

ARROW

Version/Model Number

IPN922620

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

K801912,K801912

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

5b727a49-ca87-4d37-96d1-34436432eb11

Public Version Date

February 25, 2022

Public Version Number

2

DI Record Publish Date

July 30, 2021

Package DI Number

20801902202165

Quantity per Package

10

Contains DI Package

10801902202168

Package Discontinue Date

February 23, 2022

Package Status

Not in Commercial Distribution

Package Type

Case