GL GoodLife Blood Glucose Test Strip AC (50ct in foil) 3K-01-16003C

GUDID 00389154000075

GoodLife AC Blood Glucose Test Strips

HMD BIOMEDICAL INC.

Home-use/point-of-care blood glucose/blood pressure monitoring system

• Primary Device ID: 00389154000075
• NIH Device Record Key: 120225fd-044a-4df5-86dc-dce5d42d0ab3
• Commercial Distribution Discontinuation: 2017-03-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GL GoodLife Blood Glucose Test Strip AC (50ct in foil)
• Version Model Number: AC11-Foil
• 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: 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 Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000075 [Primary]
GS1	00389154000556 [Package]; Package: Foil [100 Units]; Discontinued: 2017-03-13; Not in Commercial Distribution

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: 2016-11-08

Devices Manufactured by HMD BIOMEDICAL INC.

• 10810038636068 - Easy@Home EBG-100BLE blood glucose monitoring system: 2024-07-25 Easy@Home EBG-100BLE blood glucose monitoring system Easy@Home EBG-100BLE blood glucose meter
• 10810038636891 - Easy@Home EBG-100BLE Blood Glucose Test Strip: 2024-07-25 Easy@Home EBG-100BLE Blood Glucose Test Strip
• 04711200723892 - FIA Biomed Precisa blood glucose monitoring system: 2024-04-05 FIA Biomed Precisa blood glucose monitoring system(Meter)(K50SL)
• 04711200723922 - FIA Biomed Precisa Blood Glucose Test Strip: 2024-04-05 FIA Biomed Precisa Blood Glucose Test Strip(S100SL)
• 04711200724202 - FIA Biomed Precisa Blood Glucose Test Strip: 2024-04-05 FIA Biomed Precisa Blood Glucose Test Strip(F10SL)
• 04711200724226 - FIA Biomed Precisa Blood Glucose Test Strip: 2024-04-05 FIA Biomed Precisa Blood Glucose Test Strip(F50SL)
• 04711200724240 - FIA Biomed Precisa blood glucose monitoring system: 2024-04-05 FIA Biomed Precisa blood glucose monitoring system(Meter)(K100SL)
• 00850048540514 - LPOW blood glucose monitoring system(Meter): 2023-10-06 LPOW blood glucose monitoring system(Meter)