Guardian

GUDID 00815236021015

Reusable Liquid Crystal Forehead Thermometer

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, reusable

• Primary Device ID: 00815236021015
• NIH Device Record Key: 0c9d20da-a299-4f35-b351-b3aa96b0512e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian
• Version Model Number: 1009 NDP
• 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: 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

Customer Support Contacts

• Phone: 847-998-8580
• Email: orders@hallcrest.com
• Phone: 847-998-8580
• Email: orders@hallcrest.com
• Phone: 847-998-8580
• Email: orders@hallcrest.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236021015 [Primary]

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: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-01-15

Devices Manufactured by LCR HALLCREST, LLC.

• 20815236021057 - HemoTemp: 2022-06-28 Blood Bag Temperature Monitor
• 20815236021071 - TempTrend II: 2022-06-28
• 20815236021101 - StaFreez: 2022-06-28
• 20815236021132 - LabTemp 40: 2022-06-28
• 10815236020923 - HemoTemp II Activator: 2022-06-24
• 20815236021125 - LabTemp 20: 2022-06-24
• 20815236020173 - Crystaline® Moving Line: 2022-03-09 Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 100
• 20815236020180 - Crystaline® Moving Line: 2022-03-09 Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 50