FDK

GUDID 10859020006151

Speaking Blood Oxygen Fingertip Pulse Oximeter

FUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter 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