FDK

GUDID 00859020006369

FDK ARM CUFF BP MONITOR

Fudakang Industrial Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00859020006369
• NIH Device Record Key: c5b0d4c4-cdf6-4c15-a02e-929654585710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDK
• Version Model Number: FT-C03-V
• Company DUNS: 118811334
• Company Name: Fudakang Industrial 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859020006369 [Primary]
GS1	10859020006366 [Package]; Package: INNER PACK [4 Units]; In Commercial Distribution
GS1	20859020006363 [Package]; Package: CASE [24 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: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [FDK]

• 00859020006369: FDK ARM CUFF BP MONITOR
• 10859020006373: FDK ARM CUFF BP MONITOR
• 10859020006397: Speaking Blood Oxygen Fingertip Pulse Oximeter