FDK

GUDID 10859020006151

Speaking Blood Oxygen Fingertip Pulse Oximeter

FUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY

Pulse oximeter

• Primary Device ID: 10859020006151
• NIH Device Record Key: e4484ea4-aa21-45cf-a2ae-194880619bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDK
• Version Model Number: FT-E688
• 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: false
• 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	00859020006154 [Primary]
GS1	10859020006151 [Package]; Contains: 00859020006154; Package: Inner pack [50 Units]; In Commercial Distribution
GS1	20859020006158 [Package]; Contains: 00859020006154; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191430

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: 2021-12-02
• Device Publish Date: 2021-11-24

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