TempAlert II 8501-II-CE

GUDID 00815236020322

TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 00815236020322
• NIH Device Record Key: 0744809f-66c0-4034-a9b8-bbc8769740b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TempAlert II
• Version Model Number: 8501-II-CE
• Catalog Number: 8501-II-CE
• Company DUNS: 059247507
• Company Name: LCR HALLCREST, LLC.
• Device Count: 100
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com
• Phone: 1-800-325-3671
• Email: mailbox@sharn.com

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
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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 Conditions: 60 to 80°F and 40 to 60% relative humidity
• Storage 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	00815236020322 [Unit of Use]
GS1	30815236020323 [Primary]
GS1	40815236020320 [Package]; Contains: 30815236020323; Package: Outer Box [1 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

On-Brand Devices [TempAlert II]

• 20815236020340: TempAlert II Liquid Crystal Temperature Trend Indicator
• 10815236020336: TempAlert II Liquid Crystal Temperature Trend Indicator
• 20815236020326: TempAlert II Liquid Crystal Temperature Trend Indicator
• 20815236020319: TempAlert II Liquid Crystal Temperature Trend Indicator
• 00815236020322: TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked