Catalog Number

48738

Brand Name

Nova

Version/Model Number

SUREFLEX

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

-

Product Code

NBW

Product Code Name

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Public Device Record Key

b064c2ed-fb9f-4a90-aa55-775f066f0927

Public Version Date

August 09, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480487389

Quantity per Package

20

Contains DI Package

00385480487382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton