Enfasmart feversense Adhesive Refill Pack

GUDID 00865064000126

The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.

VIVALNK, INC.

Silicone skin adhesive tape

• Primary Device ID: 00865064000126
• NIH Device Record Key: 48472ab4-6535-4d8b-bb2e-40018576aab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enfasmart feversense Adhesive Refill Pack
• Version Model Number: VV220A
• Company DUNS: 013311479
• Company Name: VIVALNK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage 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	00865064000126 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-07-30

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• 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.