Catalog Number

805200100

Brand Name

MLB 2

Version/Model Number

805200100

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

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

BK040070,BK080012

Product Code

KSZ

Product Code Name

System, Test, Automated Blood Grouping And Antibody

Public Device Record Key

9a4871ad-1662-4903-a77e-1ae6b7293272

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

July 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-