Andnesfit Health

GUDID 04897100310070

Blood Glucose Monitoring System

ANDESFIT LIMITED

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• Primary Device ID: 04897100310070
• NIH Device Record Key: 7426569b-9b35-4014-ae94-069c001cfbc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andnesfit Health
• Version Model Number: ADF-B27
• Company DUNS: 664101036
• Company Name: ANDESFIT LIMITED
• 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: 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	04897100310070 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-11
• Device Publish Date: 2021-05-03

On-Brand Devices [Andnesfit Health]

• 00146191288527: ITO Wireless Body Fat Scale
• 00146191202776: Blood Glucose Test Strip
• 00146191202707: Blood Glucose Monitoring System
• 00146191200505: Wireless pulse oximeter
• 00146191203407: Wireless Infrared Ear/Forehead Thermometer
• 04897100310018: Wireless Pulse Oximeter
• 04897100310162: Wireless Spirometer
• 04897100310070: Blood Glucose Monitoring System
• 04897100310025: Wireless Pulse Oximeter
• 04897100310155: ITO Wireless Body Fat Scale
• 04897100310131: Wireless Non-Contact Infrared Body/Surface Thermometer
• 04897100310117: Wireless Infrared Ear/Forehead Thermometer
• 04897100310056: Wireless Arm Type Blood Pressure Monitor