CareSens N - CareSens N Blood Glucose Monitoring System - i-SENS, Inc.

Duns Number:688840958

Device Description: CareSens N Blood Glucose Monitoring System

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More Product Details

Catalog Number

-

Brand Name

CareSens N

Version/Model Number

164307

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

K083468,K083468

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

11d02cfe-205b-4ed7-8509-e6b0506d5bc0

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Additional Identifiers

Package DI Number

10885325001324

Quantity per Package

50

Contains DI Package

00885325001327

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