FeverScan Mini Disposable P436

GUDID 10815236021043

Liquid Crystal Forehead Temperature Trend Monitors

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 10815236021043
• NIH Device Record Key: c7ff0c61-9eb7-4c94-9c64-59d5fa8eb1cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FeverScan Mini Disposable
• Version Model Number: 1104
• Catalog Number: P436
• Company DUNS: 059247507
• Company Name: LCR HALLCREST, LLC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Condition 60 to 80°F and 40 to 60% Humidity.
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236021046 [Primary]
GS1	10815236021043 [Package]; Contains: 00815236021046; Package: Dispenser [100 Units]; In Commercial Distribution

FDA Product Code

• KPD: Strip, Temperature, Forehead, Liquid Crystal

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: 2020-11-03
• Device Publish Date: 2020-10-26

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