GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) 3L-10-16003A

GUDID 00389154000204

GL GoodLife Blood Glucose Test Strip(Foil)

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 00389154000204
• NIH Device Record Key: 06b04728-c9d6-4981-bc73-5f5a4fc2578c
• Commercial Distribution Discontinuation: 2016-12-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil)
• Version Model Number: 3L-10-16003A
• Catalog Number: 3L-10-16003A
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113307

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: 2016-12-13

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