CareSens N

GUDID 10885325000013

CareSens N Blood Glucose Monitoring System

i-SENS, Inc.

Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD
Primary Device ID10885325000013
NIH Device Record Keycfdedc7f-1ff6-45c1-875b-4b9bc12330e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareSens N
Version Model Number164303-201
Company DUNS688840958
Company Namei-SENS, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100885325000016 [Primary]
GS110885325000013 [Package]
Contains: 00885325000016
Package: Master Case Carton [70 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [CareSens N]

10885325000112CareSens N Blood Glucose Meter
20885325000027CareSens N Blood Glucose Test Strip
10885325000013CareSens N Blood Glucose Monitoring System

Trademark Results [CareSens N]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARESENS N
CARESENS N
88648848 not registered Live/Pending
I-SENS, INC.
2019-10-10

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