Catalog Number

6842222

Brand Name

ORTHO

Version/Model Number

6842222

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSZ

Product Code Name

SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY

Public Device Record Key

ad012eaa-a42f-42f4-aa74-60ac5630dae9

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

April 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-