COOL

GUDID 20885325000379

COOL 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 ID20885325000379
NIH Device Record Keycf45fa08-6b29-43e8-8c94-54e3652b021b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOOL
Version Model Number521100
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

Phone855-646-3231
Emailxxx@xxx.xxx
Phone855-646-3231
Emailxxx@xxx.xxx

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
GS100885325000375 [Primary]
GS110885325000372 [Package]
Contains: 00885325000375
Package: Case Pack (Mid-Box) [4 Units]
In Commercial Distribution
GS120885325000379 [Package]
Contains: 10885325000372
Package: Master Case Carton( [16 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 [COOL]

20885325000812COOL Blood Glucose Test Strip
20885325000768COOL Blood Glucose Test Strip
20885325000751COOL Blood Glucose Meter
20885325000379COOL Blood Glucose Monitoring System

Trademark Results [COOL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COOL
COOL
97435877 not registered Live/Pending
Connor Byrne
2022-05-31
COOL
COOL
97171387 not registered Live/Pending
Cool, LLC
2021-12-14
COOL
COOL
97081224 not registered Live/Pending
Solutions for Information Design, LLC
2021-10-19
COOL
COOL
90776680 not registered Live/Pending
Igloo Products Corp.
2021-06-16
COOL
COOL
90271985 not registered Live/Pending
Cool, LLC
2020-10-22
COOL
COOL
87818662 5659458 Live/Registered
PopShoppes LLC
2018-03-02
COOL
COOL
87696553 not registered Dead/Abandoned
Nanchang Coolpad Intelligent TechnologyCompany Limited
2017-11-24
COOL
COOL
87415203 not registered Dead/Abandoned
Cool Holdings, LLC
2017-04-18
COOL
COOL
87348578 not registered Dead/Abandoned
Yulong Computer Telecommunication Scientific (Shenzhen) Co., Ltd.
2017-02-24
COOL
COOL
87235693 not registered Dead/Abandoned
Rayhawk Corporation
2016-11-14
COOL
COOL
86972979 5347072 Live/Registered
Cool Tea Bar, LLC
2016-04-12
COOL
COOL
86970606 not registered Dead/Abandoned
Le Holdings Ltd.
2016-04-11

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