GL GoodLife Glucose Control Solutions 3C-01-160032

GUDID 00389154000549

GL GoodLife Glucose Control Solution

HMD BIOMEDICAL INC.

Glucose IVD, control

• Primary Device ID: 00389154000549
• NIH Device Record Key: 24d16c22-4bba-4589-bbac-be7367ecc221
• Commercial Distribution Discontinuation: 2017-03-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GL GoodLife Glucose Control Solutions
• Version Model Number: 3C-01-160032
• Catalog Number: 3C-01-160032
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000549 [Primary]
GS1	00389154000563 [Package]; Package: [792 Units]; Discontinued: 2017-03-06; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113307

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-17

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