COMPER

GUDID 06970528391109

COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 06970528391109
• NIH Device Record Key: adb82991-0f1c-45b2-967b-3eb870d1b244
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPER
• Version Model Number: IR-FT
• 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	06970528391109 [Primary]
GS1	16970528391106 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	26970528391103 [Package]; Package: [52 Units]; In Commercial Distribution
GS1	36970528391100 [Package]; Package: [51 Units]; In Commercial Distribution
GS1	46970528391107 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191668

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-11-12

On-Brand Devices [COMPER]

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