GL GoodLife Glucose Control Solution(Level 1) 3C-01-810032

GUDID 00389154000716

GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System

HMD BIOMEDICAL INC.

Glucose IVD, control

• Primary Device ID: 00389154000716
• NIH Device Record Key: dff656fb-df0c-4680-947c-bbec3b07d429
• Commercial Distribution Discontinuation: 2018-12-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GL GoodLife Glucose Control Solution(Level 1)
• Version Model Number: GL GCS
• Catalog Number: 3C-01-810032
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-855-692-3511
• Email: Sales@gl-daibetes.com
• Phone: 1-855-692-3511
• Email: Sales@gl-daibetes.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000440 [Primary]
GS1	00389154000716 [Package]; Contains: 00389154000440; Package: box [650 Units]; Discontinued: 2018-12-28; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120064

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-28
• Device Publish Date: 2017-10-30

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