Catalog Number

-

Brand Name

Tyson Bio 50H Control Solution (Level 3)

Version/Model Number

Tyson Bio 50H

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170079,K170079,K170079

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

2f721e87-c44c-462a-bb37-09e4d9acdcd9

Public Version Date

December 04, 2019

Public Version Number

2

DI Record Publish Date

March 11, 2019

Package DI Number

24719869702375

Quantity per Package

1000

Contains DI Package

04719869702371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-