Pro Comfort Blood Glucose Monitor Kit 19871-5270-30

GUDID 00198715270303

BLOOD GLUCOSE MONITOR KIT BGM107 Meter BGM107 100 x Test Strips Lancing Device 100 x Lancets CR2032 Carrying Bag Instruction For Use (Read before use) Quick Start Guide

Care Living Diagnostics Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00198715270303
• NIH Device Record Key: 1c931e2d-1bff-499d-98ec-78a7c1ba5c76
• Commercial Distribution Discontinuation: 2025-02-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pro Comfort Blood Glucose Monitor Kit
• Version Model Number: BGM107
• Catalog Number: 19871-5270-30
• Company DUNS: 125354643
• Company Name: Care Living Diagnostics Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198715270303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052208

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2025-03-05
• Device Publish Date: 2025-02-25

Devices Manufactured by Care Living Diagnostics Inc.

• 00198715270303 - Pro Comfort Blood Glucose Monitor Kit: 2025-03-05BLOOD GLUCOSE MONITOR KIT BGM107 Meter BGM107 100 x Test Strips Lancing Device 100 x Lancets CR2032 Carrying Bag Instruction For Use (Read before use) Quick Start Guide
• 00198715270303 - Pro Comfort Blood Glucose Monitor Kit: 2025-03-05 BLOOD GLUCOSE MONITOR KIT BGM107 Meter BGM107 100 x Test Strips Lancing Device 100 x Lancets CR2032 Carrying Bag Instruction For
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• 10383568100205 - CareLiving Pressure Activated Safety lancet 21G: 2024-07-01 Pressure Activated Safety lancet 21G*1.8mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and l
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• 10383568100731 - CareLiving MM1100 Blood Glucose Test Strips 100ct: 2024-04-29 Blood Glucose Test Strips,50ct/box,two box, for use with blood glucose monitoring system
• 10383568100748 - CareLiving MM1100 Blood Glucose Test Strips 50ct: 2024-04-29 Blood Glucose Test Strips,2 bottles of 25 strips in one 50 strip box, for use with blood glucose monitoring system