Andnesfit Health

GUDID 04897100310025

Wireless Pulse Oximeter

ANDESFIT LIMITED

Pulse oximeter, battery-powered

• Primary Device ID: 04897100310025
• NIH Device Record Key: 19d3857f-b915-481e-850a-f2af59532bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andnesfit Health
• Version Model Number: ADF-B06
• 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	04897100310025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170965

FDA Product Code

• DQA: Oximeter

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

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• 04897100310070: Blood Glucose Monitoring System
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• 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