TELCARE, LLC

Address:600 West Ridge Road, Suite 200,Upper Chichester,PA,19061,US

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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) (4) Calculator/Data Processing Module, For Clinical Use (JQP) (1) Glucose Oxidase, Glucose (CGA) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Clear

BioTel Care® Test Strips - 00859519002018 Catalog Number : TT0003

Device Description : Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Contr Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution.

Device Class :

Duns Number: 116979417

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 50

BioTel Care® Double Control Solution - 00859519002056 Catalog Number : TC0003

Device Description : Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.

Device Class : 1

Duns Number: 116979417

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

BioTel Care® Blood Glucose Monitoring System - 00859519002223 Catalog Number : TM0008

Device Description : The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strip The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). The BioTel Care® Blood Glucose Meter, when used with the BioTel Care® Blood Glucose Test Strip, quantitatively measures glucose in capillary whole blood. The BioTel Care® Glucose Control Solutions are used by patients to verify the performance of the BioTel Care® test strips and BioTel Care® meter.

Device Class :

Duns Number: 116979417

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Telserve® Data Management System - 00859519002247 Catalog Number :

Device Description : The Telserve® Data Management System is an accessory to blood glucose monitoring The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management.

Device Class : 1

Duns Number: 116979417

Premarket Exempt : No

Product Code : JQP

Prescription Use : No

Device Count : 1

BioTel Care BGM 4 - 00859519002407 Catalog Number : TM0009

Device Description : BioTel Care BGM 4

Device Class : 2

Duns Number: 116979417

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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