i-SENS, Inc.

Address:4th floor, 39-36, Nonhyeon-ro 46beon-gil,,Namdong-gu Incheon,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Test, Blood Glucose, Over The Counter (NBW) (6) Glucose Oxidase, Glucose (CGA) (4) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (3)

Premarket Exempt

Clear

CareSens N - 00885325001105 Catalog Number :

Device Description : CareSens N Blood Glucose Monitoring System (White)

Device Class : 2

Duns Number: 688840958

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

KetoSens - 00885325001198 Catalog Number :

Device Description : KetoSens B-Ketone Test Strip (individual foiled packs x 30)

Device Class :

Duns Number: 688840958

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 30

CareSens N - 00885325001211 Catalog Number :

Device Description : CareSens N Blood Glucose Monitoring System with Test Strips (10T)

Device Class : 2

Duns Number: 688840958

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

CareSens N - 00885325001242 Catalog Number :

Device Description : CareSens N Blood Glucose Test Strip

Device Class :

Duns Number: 688840958

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 25

CareSens II - 00885325001266 Catalog Number :

Device Description : CareSens II Blood Glucose Monitoring System (Basic meter set)

Device Class : 2

Duns Number: 688840958

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

KetoSens - 00885325001273 Catalog Number :

Device Description : KetoSens B-Ketone Test Strip (individually foiled packs x 30) with 30T lancets

Device Class :

Duns Number: 688840958

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 30

KetoSens - 00885325001280 Catalog Number :

Device Description : KetoSens B-Ketone 10T Test Strips with 10T lancets

Device Class :

Duns Number: 688840958

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 10

CareSens N - 00885325001310 Catalog Number :

Device Description : CareSens N Blood Glucose Monitoring System

Device Class : 2

Duns Number: 688840958

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

CareSens N - 00885325001327 Catalog Number :

Device Description : CareSens N Blood Glucose Monitoring System

Device Class : 2

Duns Number: 688840958

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

CareSens N Plus BT - 00885325001372 Catalog Number :

Device Description : CareSens N Plus BT Blood Glucose Monitoring System

Device Class : 2

Duns Number: 688840958

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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