FDK

GUDID 10859020006397

Speaking Blood Oxygen Fingertip Pulse Oximeter

Fudakang Industrial Inc.

Pulse oximeter

• Primary Device ID: 10859020006397
• NIH Device Record Key: 17acb4ae-eec9-4024-bee5-f09d3a43b086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDK
• Version Model Number: FT-E688 Plus
• 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: 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	00859020006390 [Primary]
GS1	10859020006397 [Package]; Contains: 00859020006390; Package: Inner Pack [50 Units]; In Commercial Distribution
GS1	20859020006394 [Package]; Contains: 00859020006390; Package: Case [100 Units]; In Commercial Distribution

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: 2025-04-22
• Device Publish Date: 2025-04-14

On-Brand Devices [FDK]

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