COMPER

GUDID 06970528391130

COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.

Infrared patient thermometer, ear

• Primary Device ID: 06970528391130
• NIH Device Record Key: 574bff16-510d-4be1-acab-918099d089b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPER
• Version Model Number: IR-EFT
• Company DUNS: 551095493
• Company Name: COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970528391130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202481

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: 2021-11-26
• Device Publish Date: 2021-11-18

On-Brand Devices [COMPER]

• 06970528391109: IR-FT
• 06970528391130: IR-EFT
• 06974415521136: IR-EFT
• 06974415521105: IR-FT