GL GoodLife 3K-01-16003C

GUDID 00389154000198

GL GoodLife AC-300 Blood Glucose Monitoring System

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00389154000198
• NIH Device Record Key: ff15bbdf-cfaf-4b2a-9286-5165646c1fd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GL GoodLife
• Version Model Number: AC11
• Catalog Number: 3K-01-16003C
• Company DUNS: 658644174
• Company Name: HMD BIOMEDICAL 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: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000198 [Primary]
GS1	00389154000655 [Package]; Package: [63 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140150

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [GL GoodLife ]

• 00389154000372: GL GoodLife Blood Glucose Monitoring System(Cloudia)
• 00389154000198: GL GoodLife AC-300 Blood Glucose Monitoring System
• 04711200721850: The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)