CareLiving Blood Glucose Monitoring System 83568-1007-1

GUDID 00383568100710

BLOOD GLUCOSE MONITORING SYSTEM CareLiving MM1100 Meter CareLiving MM1100 100 x Test Strips CareLiving Lancing Device CareLiving 100 x Lancets 2 x 3-volt Lithium Batteries (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: 00383568100710
• NIH Device Record Key: c87da990-5d3c-4361-842c-2ee4e5740add
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareLiving Blood Glucose Monitoring System
• Version Model Number: MM1100 KIT
• Catalog Number: 83568-1007-1
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383568100710 [Primary]
GS1	10383568100717 [Package]; Package: case [40 Units]; Discontinued: 2023-11-15; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111456

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: 2023-11-22
• Device Publish Date: 2023-11-14

Devices Manufactured by Care Living Diagnostics Inc.

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• 00383568100802 - CareLiving Blood Glucose Monitor Kit: 2024-07-24 BLOOD GLUCOSE MONITOR KIT CareLiving BGM101 Meter CareLiving BGM101 100 x Test Strips CareLiving Lancing Device CareLiving 100 x
• 10383568100243 - CareLiving Pressure Activated Safety lancet 26G: 2024-07-04 Pressure Activated Safety lancet 26G*1.8mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and l
• 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
• 00383568100727 - CareLiving MM1100 Blood Glucose Meter: 2024-04-29 CareLiving MM1100 Meter
• 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
• 00383568100758 - CareLiving MM1100 Control Solution For Blood Glucose: 2024-04-29 CareLiving MM1100 Control Solution