FDK

GUDID 06955647600011

FUDAKANG INDUSTRIAL CO., LTD.

General-purpose patient temperature probe, single-use

• Primary Device ID: 06955647600011
• NIH Device Record Key: f5ca3ac9-c977-4a8f-8da3-483c62c2d969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDK
• Version Model Number: BT-A11CN
• Company DUNS: 544522665
• Company Name: FUDAKANG INDUSTRIAL CO., LTD.
• 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	06955647600011 [Primary]
GS1	16955647600018 [Package]; Package: Inner Box [30 Units]; In Commercial Distribution
GS1	26955647600015 [Package]; Package: case [360 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101387

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [FDK]

• 06955647600011: BT-A11CN
• 16955647600063: BT-A41CN-BT