Finicare

GUDID 06971522820039

Shenzhen Finicare Co., Ltd

Infrared patient thermometer, ear/skin

• Primary Device ID: 06971522820039
• NIH Device Record Key: c597b0d8-c8d6-4ce2-a412-08c67234bfcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Finicare
• Version Model Number: FC-IR1010
• 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	06971522820039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181215

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: 2019-11-08
• Device Publish Date: 2019-10-31

On-Brand Devices [Finicare]

• 06971522820138: FC-IR1012
• 06971522820121: FC-IR1011
• 06971522820114: FC-IR3010
• 06971522820107: FC-IR1030
• 06971522820091: FC-IR2000
• 06971522820053: FC-IR400
• 06971522820039: FC-IR1010
• 06971522820022: FC-IR100
• 06971522820015: FC-IR300
• 06971522820176: FC-IR204
• 06971522820008: FC-IR101
• 06971522820169: FC-IR104
• 06971522820220: FC-IR207
• 06971522820213: FC-IR206
• 06971522820084: FC-IR205
• 06971522820077: FC-IR105
• 06971522820329: FC-BP113
• 06971522820312: FC-BP103
• 06971522820305: FC-BP120
• 06971522820299: FC-BP112
• 06971522820282: FC-BP111
• 06971522820275: FC-BP110
• 06971522820268: FC-BP102
• 06971522820251: FC-BP101
• 06971522820244: FC-BP100
• 06971522820411: FC-BP131
• 06971522820404: FC-BP130
• 06971522820497: FC-BP121
• 06971522820350: FC-BP210
• 06971522820343: FC-BP201
• 06971522820336: FC-BP200
• 06971522820381: FC-BP221
• 06971522820374: FC-BP220
• 06971522820367: FC-BP211