Fifty50 Sport - Fifty50 Sport Blood Glucose Monitoring System 2.0 - i-SENS, Inc.

Duns Number:688840958

Device Description: Fifty50 Sport Blood Glucose Monitoring System 2.0

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More Product Details

Catalog Number

-

Brand Name

Fifty50 Sport

Version/Model Number

163424-201

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

-

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

K120351,K120351

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

391ad575-9ba6-4002-a321-853a46a686d8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10892896000267

Quantity per Package

50

Contains DI Package

00892896000260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton

"I-SENS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 20