CareLiving Blood Glucose Monitor Kit 83568-1008-02

GUDID 00383568100802

BLOOD GLUCOSE MONITOR KIT CareLiving BGM101 Meter CareLiving BGM101 100 x Test Strips CareLiving Lancing Device CareLiving 100 x Lancets 2 x AAA Batteries 1 Control Solution Carrying Bag Instruction For Use (Read before use) Quick Start Guide

Care Living Diagnostics Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00383568100802
• NIH Device Record Key: eb7604a1-593a-4190-898e-d560fe437349
• Commercial Distribution Discontinuation: 2024-07-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CareLiving Blood Glucose Monitor Kit
• Version Model Number: BGM101
• Catalog Number: 83568-1008-02
• 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	00383568100802 [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: 2024-07-24
• Device Publish Date: 2024-07-16

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