COMPER

GUDID 06970528391109

COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.

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