Bruno - Blood Glucose Test Strips - BRUNO PHARMA INNOVATIONS, LLC

Duns Number:080469071

Device Description: Blood Glucose Test Strips

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More Product Details

Catalog Number

-

Brand Name

Bruno

Version/Model Number

MD6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Device Record Status

Public Device Record Key

3ea54d9f-bac8-4aac-bed0-ff0e6fe20782

Public Version Date

November 01, 2021

Public Version Number

4

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRUNO PHARMA INNOVATIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1