Catalog Number

-

Brand Name

TysonBio AC200 Blood Glucose Monitoring System

Version/Model Number

TysonBio AC200

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101543,K101543

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

cb258ebc-1c00-47ee-b316-0c04a6b05980

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2017

Package DI Number

14719869701470

Quantity per Package

80

Contains DI Package

04719869701473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-