Calibeur

GUDID 06970000910811

Shenzhen Calibeur Industries Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 06970000910811
• NIH Device Record Key: b1407ef5-8d5c-4de8-bbd2-be2fb0e01d23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibeur
• Version Model Number: DT-8836P
• Company DUNS: 546723214
• Company Name: Shenzhen Calibeur Industries 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970000910811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191251

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [Calibeur]

• 06970000910828: DT-8836T
• 06970000910811: DT-8836P