FondCircle

GUDID 00850070979191

Blood Glucose Test Strips

FondCircle Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850070979191
• NIH Device Record Key: 14aa1aeb-40fd-4d3f-a442-74c4162624bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FondCircle
• Version Model Number: M1-S50
• Company DUNS: 060715854
• Company Name: FondCircle 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850070979191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191657

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-06
• Device Publish Date: 2025-02-26

On-Brand Devices [FondCircle]

• 00850070979177: Infrared Thermometer
• 00850070979160: Digital Thermometer
• 00850070979153: Pulse Oximeter
• 00850070979146: Blood Pressure Monitor
• 00850070979139: Blood Pressure Monitor
• 00850070979122: Upper Arm Blood Pressure Monitor
• 00850070979115: Wrist Blood Pressure Monitor
• 00850070979108: Weight Scale
• 00850070979092: Body Fat Scale
• 00850070979085: Body Fat Scale
• 00850070979078: Body Fat Scale
• 00850070979061: Body Fat Scale
• 00850070979054: Blood Glucose Monitoring System
• 00850070979047: Blood Glucose Monitoring System
• 00850070979191: Blood Glucose Test Strips
• 00850070979184: Sterile Lancet
• 00850070979214: Blood Glucose Test Strips Kit
• 00850070979207: Blood Glucose Test Strips Kit
• 00850070979238: Blood Glucose Monitoring
• 00850070979221: Blood Glucose Test Strips
• 00850070979252: M1-S50