Catalog Number

-

Brand Name

NuvoMed

Version/Model Number

P5228 BGM-6/0352

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

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

b57e17e7-45e2-475a-bc60-e729fffdb20f

Public Version Date

April 09, 2018

Public Version Number

1

DI Record Publish Date

March 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-