BioTel Care® Blood Glucose Monitoring System TM0008

GUDID 00859519002223

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.

TELCARE, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00859519002223
• NIH Device Record Key: aba65b22-e349-452a-ae76-b9f9d4a28f29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTel Care® Blood Glucose Monitoring System
• Version Model Number: BGM
• Catalog Number: TM0008
• Company DUNS: 116979417
• Company Name: TELCARE, LLC
• Device Count: 1
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 877-777-4710
• Email: support@telcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859519002223 [Primary]
GS1	00859519002339 [Package]; Package: [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110571

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-19
• Device Publish Date: 2019-03-11

Devices Manufactured by TELCARE, LLC

• 00859519002391 - BioTel Care BGM 4: 2021-01-25 BioTel Care BGM 4
• 00859519002261 - BioTel Care® Test Strips: 2019-03-19 Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution.
• 10859519002053 - BioTel Care® Double Control Solution: 2019-03-19 Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.
• 00859519002223 - BioTel Care® Blood Glucose Monitoring System: 2019-03-19The 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.
• 00859519002223 - BioTel Care® Blood Glucose Monitoring System: 2019-03-19 The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2).
• 00859519002247 - Telserve® Data Management System: 2019-03-19 The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood