AUPO

GUDID 16955647600087

Blood Pressure Monitor

FUDAKANG INDUSTRIAL CO., LTD.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16955647600087
• NIH Device Record Key: 6b1cfeef-4387-4bbb-971f-490509ec608a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUPO
• Version Model Number: FT-B13W
• Company DUNS: 544522665
• Company Name: FUDAKANG INDUSTRIAL CO., LTD.
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06955647600080 [Primary]
GS1	16955647600087 [Package]; Contains: 06955647600080; Package: Inner Box [6 Units]; In Commercial Distribution
GS1	26955647600084 [Package]; Contains: 06955647600080; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150430

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: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [AUPO]

• 16955647600087: Blood Pressure Monitor
• 16955647600070: Infrared Thermometer