Primary Device ID | 20885325000812 |
NIH Device Record Key | 8d3cdf1e-94c1-46fd-b54f-bac2a55db057 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | COOL |
Version Model Number | 520010 |
Company DUNS | 688840958 |
Company Name | i-SENS, Inc. |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 1-800-429-5001 |
xxx@xxx.xxx | |
Phone | 1-800-429-5001 |
xxx@xxx.xxx |
Storage Environment Temperature | Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885325000818 [Primary] |
GS1 | 10885325000815 [Package] Contains: 00885325000818 Package: Case Pack (Mid-Box) [12 Units] In Commercial Distribution |
GS1 | 20885325000812 [Package] Contains: 10885325000815 Package: Master Case Carton [45 Units] In Commercial Distribution |
GS1 | 50885325000813 [Unit of Use] |
CGA | Glucose Oxidase, Glucose |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-23 |
20885325000812 | COOL Blood Glucose Test Strip |
20885325000768 | COOL Blood Glucose Test Strip |
20885325000751 | COOL Blood Glucose Meter |
20885325000379 | COOL Blood Glucose Monitoring System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COOL 97435877 not registered Live/Pending |
Connor Byrne 2022-05-31 |
COOL 97171387 not registered Live/Pending |
Cool, LLC 2021-12-14 |
COOL 97081224 not registered Live/Pending |
Solutions for Information Design, LLC 2021-10-19 |
COOL 90776680 not registered Live/Pending |
Igloo Products Corp. 2021-06-16 |
COOL 90271985 not registered Live/Pending |
Cool, LLC 2020-10-22 |
COOL 87818662 5659458 Live/Registered |
PopShoppes LLC 2018-03-02 |
COOL 87696553 not registered Dead/Abandoned |
Nanchang Coolpad Intelligent TechnologyCompany Limited 2017-11-24 |
COOL 87415203 not registered Dead/Abandoned |
Cool Holdings, LLC 2017-04-18 |
COOL 87348578 not registered Dead/Abandoned |
Yulong Computer Telecommunication Scientific (Shenzhen) Co., Ltd. 2017-02-24 |
COOL 87235693 not registered Dead/Abandoned |
Rayhawk Corporation 2016-11-14 |
COOL 86972979 5347072 Live/Registered |
Cool Tea Bar, LLC 2016-04-12 |
COOL 86970606 not registered Dead/Abandoned |
Le Holdings Ltd. 2016-04-11 |