FeverScan Ultra

GUDID 00815236020919

Reusable Forehead Thermometer

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 00815236020919
• NIH Device Record Key: 44981e6f-90d6-413e-bfc0-9f001f52547e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FeverScan Ultra
• Version Model Number: 1026B1
• 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: 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: 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 Conditions: 60 to 80°F and 40 to 60% Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236020919 [Primary]
GS1	10815236020916 [Package]; Package: 1CTN [1 Units]; In Commercial Distribution
GS1	20815236020913 [Package]; Contains: 10815236020916; Package: 1BX [1 Units]; In Commercial Distribution
GS1	30815236020910 [Package]; Contains: 20815236020913; Package: 12BG [12 Units]; In Commercial Distribution
GS1	40815236020917 [Package]; Contains: 10815236020916; Package: 5BG [5 Units]; In Commercial Distribution
GS1	50815236020914 [Package]; Package: 2BX [2 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-09

On-Brand Devices [FeverScan Ultra]

• 00815236020919: Reusable Forehead Thermometer
• 00815236020391: FeverScan Ultra Reusable Forehead Thermometer
• 00815236021039: Reusable Liquid Crystal Forehead Thermometer - 12 Event, Celsius only with Blank Tabs
• 00815236021022: Reusable Liquid Crystal Forehead Thermometer - 12 Event, Dual Scale, with Blank Tabs