Catalog Number

-

Brand Name

VeraSens Voice

Version/Model Number

282442

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

K121133,K121133

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

bbac72ae-767c-4139-aafb-23e67f880332

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10857513006190

Quantity per Package

70

Contains DI Package

00857513006193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton