Etekcity Non-Contact Infrared Body Thermometer

GUDID 00817915020142

ETEKCITY CORPORATION

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• Primary Device ID: 00817915020142
• NIH Device Record Key: cc14c847-db73-43e5-83ca-496627bc297c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etekcity Non-Contact Infrared Body Thermometer
• Version Model Number: HTD8816C
• Company DUNS: 079578783
• Company Name: ETEKCITY CORPORATION
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817915020142 [Primary]
GS1	10817915020149 [Package]; Package: Outer Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171888

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: 2020-07-20
• Device Publish Date: 2020-07-10

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