One Drop

GUDID 20859509006068

System Kit, Blood Glucose Meter, One Drop, mg/dL, (25ct)

INFORMED DATA SYSTEMS INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 20859509006068
• NIH Device Record Key: 1624b1e9-19e6-4274-9088-30c01ba504b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Drop
• Version Model Number: 8000-10584
• Company DUNS: 079628966
• Company Name: INFORMED DATA SYSTEMS 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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: 1-800-437-1474
• Email: customerservice@onedrop.today

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859509006064 [Primary]
GS1	20859509006068 [Package]; Contains: 00859509006064; Package: [8 Units]; In Commercial Distribution

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2018-12-03
• Device Publish Date: 2017-10-01

On-Brand Devices [One Drop]

• 20859509006068: System Kit, Blood Glucose Meter, One Drop, mg/dL, (25ct)
• 20859509006051: Test Strips, One Drop, 50ct
• 10859509006023: System Kit, Blood Glucose Meter, One Drop, mgd/L
• 00859509006019: Blood Glucose Meter, One Drop, mg/dL