iProvèn

GUDID 08719699636552

DMT-77 Measures body temperature

Sevenground Trading B.V.

Infrared patient thermometer, ear/skin

• Primary Device ID: 08719699636552
• NIH Device Record Key: b22949a3-cece-4753-b33e-9d872c8c6d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iProvèn
• Version Model Number: DMT-77BT
• Company DUNS: 492177197
• Company Name: Sevenground Trading B.V.
• 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

Customer Support Contacts

• Phone: 18555178225
• Email: jenille.rabeje@sevenground.com
• Phone: 18555178225
• Email: jenille.rabeje@sevenground.com
• Phone: 18555178225
• Email: jenille.rabeje@sevenground.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719699636552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172795

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: 2022-12-06
• Device Publish Date: 2022-11-28

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