Catalog Number

-

Brand Name

Tyson Bio HT100-B Blood Glucose Monitoring System

Version/Model Number

HT100-B

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

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

11b0a5cf-b197-4b9d-b30f-03a0bf0db4ff

Public Version Date

August 19, 2020

Public Version Number

1

DI Record Publish Date

August 11, 2020

Package DI Number

14719869702002

Quantity per Package

80

Contains DI Package

04719869702005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-