SimpliCare

GUDID 06971522821005

Shenzhen Finicare Co., Ltd

Infrared patient thermometer, ear/skin

• Primary Device ID: 06971522821005
• NIH Device Record Key: 49caef36-ba16-4478-a9f2-dcb7cfcc2daf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimpliCare
• Version Model Number: FC-IR206
• Company DUNS: 544584610
• Company Name: Shenzhen Finicare 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: false
• 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	06971522821005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243136

FDA Product Code

• FLL: Continuous Measurement Thermometer

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: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by Shenzhen Finicare Co., Ltd

• 06971522821005 - SimpliCare: 2025-12-12
• 06971522821005 - SimpliCare: 2025-12-12
• 06971522820367 - Finicare: 2023-10-19
• 06971522820374 - Finicare: 2023-10-19
• 06971522820381 - Finicare: 2023-10-19
• 06971522820336 - Finicare: 2023-10-18
• 06971522820343 - Finicare: 2023-10-18
• 06971522820350 - Finicare: 2023-10-18
• 06971522820497 - Finicare: 2023-10-05