Andesfit

GUDID 04897100310254

Upper Arm Electronic Blood Pressure Monitor

ANDESFIT LIMITED

Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 04897100310254
• NIH Device Record Key: f5951e9e-5561-4149-8621-b109cb4e50d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andesfit
• Version Model Number: ADF-B61
• 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	04897100310254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2023-05-10
• Device Publish Date: 2023-05-02

On-Brand Devices [Andesfit ]

• 00146191200604: Wireless Pules Oximeter
• 00146191210221: Wireless Wrist Type Blood Pressure Monitor
• 00146191201908: Wireless Arm Type Blood Pressure monitor
• 00146191010005: Wireless Spirometer
• 00146191203803: Wireless Non-Contact Infrared Body/Surface Thermometer
• 04897100310254: Upper Arm Electronic Blood Pressure Monitor