Catalog Number

-

Brand Name

CareSens N Voice Multi

Version/Model Number

164446-201

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132288,K132288

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

87c5f832-b8f3-464f-a428-76041f331329

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Package DI Number

10885325000846

Quantity per Package

70

Contains DI Package

00885325000849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton