FDK

GUDID 00867464000263

FDK ARM CUFF BP MONITOR

FUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00867464000263
• NIH Device Record Key: cc81a5b5-de9b-4fe3-8038-6bfd18cabf66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDK
• Version Model Number: FT-C12B-V
• Company DUNS: 030152184
• Company Name: FUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867464000263 [Primary]
GS1	10867464000260 [Package]; Package: Case [24 Units]; In Commercial Distribution
GS1	20867464000267 [Package]; Package: Inner Pack [3 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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-17
• Device Publish Date: 2016-12-21

On-Brand Devices [FDK]

• 00867464000294: FDK ARM CUFF BP MONITOR
• 00867464000287: FDK ARM CUFF BP MONITOR
• 00867464000270: FDK ARM CUFF BP MONITOR
• 00867464000263: FDK ARM CUFF BP MONITOR
• 00867464000256: FDK ARM CUFF BP MONITOR
• 00867464000249: FDK WRIST CUFF BP MONITOR
• 00867464000232: FDK WRIST CUFF BP MONITOR
• 00867464000225: FDK WRIST CUFF BP MONITOR
• 00867464000218: FDK WRIST CUFF BP MONITOR
• 00867464000201: FDK WRIST CUFF BP MONITOR
• 00859020006260: FDK ARM CUFF BP MONITOR
• 00859020006246: FDK ARM CUFF BP MONITOR
• 00859020006208: FDK Non-Contact Infrared Thermometer
• 00859020006130: FDK WRIST CUFF BP MONITOR
• 00859020006116: FDK ARM CUFF BP MONITOR
• 00859020006079: FDK NON-CONTACT INFRARED THERMOMETER
• 20859020006066: FDK NON-CONTACT INFRARED THERMOMETER
• 00859020006055: FDK FOREHEAD & EAR INFRARED THERMOMETER
• 00859020006048: FDK EAR TYPE INFRARED THERMOMETER
• 00859020006031: FDK DIGITAL THERMOMETER
• 00859020006024: FDK DIGITAL THERMOMETER
• 00859020006017: FDK DIGITAL THERMOMETER
• 00859020006000: FDK ARM CUFF BP MONITOR
• 00859020006321: FDK ARM CUFF BP MONITOR
• 00859020006178: FDK DIGITAL THERMOMETER
• 00859020006444: FDK NON-CONTACT INFRARED THERMOMETER
• 10859020006434: FDK DIGITAL THERMOMETER
• 10859020006472: FDK NON-CONTACT INFRARED THERMOMETER
• 10859020006151: Speaking Blood Oxygen Fingertip Pulse Oximeter
• 00859020006383: FDK SPEAKING NON-CONTACT INFRARED THERMOMETER