Catalog Number

-

Brand Name

OneTouch Verio Reflect

Version/Model Number

023-927

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193475,K193475

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

3f141f13-4f4a-4200-90a9-4b9c40b91b04

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 28, 2020

Package DI Number

20353885011697

Quantity per Package

4

Contains DI Package

00353885011693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper