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.

• 10383568300445 - EasyLife Safety Pen Needles 4MM 31G 100pcs: 2025-09-26 EasyLife Safety Pen Needles 4MM 31G 100pcs
• 10383568300452 - EasyLife Safety Pen Needles 5MM 31G 100pcs: 2025-09-26 EasyLife Safety Pen Needles 5MM 31G 100pcs
• 10383568400244 - EasyLife Mini Safety Pen Needles 4MM 31G 100pcs: 2025-09-26 EasyLife Mini Safety Pen Needles 4MM 32G 100pcs
• 10383568400312 - EasyLife Insulin syringe 30G 1/2” 1cc 100pcs: 2025-09-26 EasyLife Insulin syringe 30G 1/2” 1cc 100pcs
• 10383568400329 - EasyLife Insulin syringe 31G 5/16" 1cc 100pcs: 2025-09-26 EasyLife Insulin syringe 31G 5/16" 1cc 100pcs
• 10383568400336 - EasyLife Insulin syringe 30G 5/16" 1cc 100pcs: 2025-09-26 EasyLife Insulin syringe 30G 5/16" 1cc 100pcs
• 10383568400428 - EasyLife safety Insulin syringe 29G 1/2" 1ml/cc 100pcs: 2025-09-26 EasyLife safety Insulin syringe 29G 1/2" 1ml/cc 100pcs
• 10383568400435 - EasyLife safety Insulin syringe 30G 1/2” 1/2ml/cc 100pcs: 2025-09-26 EasyLife safety Insulin syringe 30G 1/2” 1/2ml/cc 100pcs