Enfasmart feversense Continuous monitoring thermometer

GUDID 00865064000164

The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

VIVALNK, INC.

Wireless patient thermometer, reusable

• Primary Device ID: 00865064000164
• NIH Device Record Key: f95630e7-d463-4a63-9007-f4bccc20358a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enfasmart feversense Continuous monitoring thermometer
• Version Model Number: VV220
• Company DUNS: 013311479
• Company Name: VIVALNK, INC.
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865064000164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162137

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: 2018-08-30
• Device Publish Date: 2018-07-30

Devices Manufactured by VIVALNK, INC.

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• 00860008259202 - Hydrogel Adhesive: 2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci
• 00860008259219 - Hydrogel Adhesive: 2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci
• 00865064000195 - Hydrogel Adhesive: 2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci
• 00865064000157 - Continuous ECG Platform: 2020-02-07 VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display
• 00865064000188 - Hydrogel Adhesive: 2020-02-07 The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
• 00865064000126 - Enfasmart feversense Adhesive Refill Pack: 2019-10-23 The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.