FDK

GUDID 16955647600063

FUDAKANG INDUSTRIAL CO., LTD.

General-purpose patient temperature probe, single-use

• Primary Device ID: 16955647600063
• NIH Device Record Key: 497c5a8a-6d7e-446e-9de6-5378fceef2a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDK
• Version Model Number: BT-A41CN-BT
• 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	06955647600066 [Primary]
GS1	16955647600063 [Package]; Contains: 06955647600066; Package: Inner Box [8 Units]; In Commercial Distribution
GS1	26955647600060 [Package]; Contains: 06955647600066; Package: Case [96 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160308

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [FDK]

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