FDA.reportPublic FDA data

COOL

Primary DI
20885325000768
Brand
COOL
Company
i-SENS, Inc.
Model
520050
Device description
COOL Blood Glucose Test Strip
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103396000COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTIONI-Sens, Inc.2011-09-27NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885325000761PackageGS112In Commercial Distribution
20885325000768PackageGS145In Commercial Distribution
00885325000764PrimaryGS10
50885325000769Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088532500076110885325000761
2088532500076820885325000768
00885325000764008853250007648853250007640885325000764
5088532500076950885325000769

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature33.8 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-646-3231xxx@xxx.xxx

Regulatory Flags#

DUNS number
688840958
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885325000856KetoSens276261-2012020-11-10
00885325001495KetoSens2762652020-11-10
10885325000853KetoSens276261-2012020-11-10
10885325001492KetoSens2762652020-11-10
00885325001181CareSens S Fit BT1645092023-07-11
00885325001761CareSens N Voice Square1645022023-07-11
10885325001188CareSens S Fit BT1645092023-07-11
00885325001518CareSens S Fit1645062023-07-11
10885325001768CareSens N Voice Square1645022023-07-11
00194631000055Tempo3430042023-01-26
00810011730045TempoPGUHA-00000332023-01-26
00810011730069TempoPGUHA-00000392023-01-26
00875011006712Greater Goods Essential6712023-01-26
00875011006767Greater Goods Essential6762023-01-26
00885325000542CareSensPGUHA-00000022023-01-26
00885325000924CareSensPGUHA-00000032023-01-26
00885325001556CareSensPGUHA-00000602023-01-26
00885325001716CareSoft1640062023-01-26
00885325001778CareSens N Feliz1645072023-01-26
00885325001785CareSens N1641052023-01-26

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Primary DI, Brand, Company table
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00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00383568100826CareLiving BGM101 Blood Glucose MeterCare Living Diagnostics Inc.CGA2024-08-07
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00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
00383568100734CareLiving MM1100 Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2024-04-19
00383568100741CareLiving MM1100 Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2024-04-19
00383568100819CareLiving Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2023-11-15
00383568100710CareLiving MM1100 Blood Glucose Monitoring SystemCare Living Diagnostics Inc.CGA2023-11-14
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
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MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
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10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
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