Guardian

Basic Information

• Brand Name: Guardian
• Primary DI: 00815236021015
• Version / Model: 1009 NDP
• Company Name: LCR HALLCREST, LLC.
• Labeler DUNS: 059247507
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 2
• Public Version Date: 2020-02-24
• Public Version Status: Update
• Public Device Record Key: 0c9d20da-a299-4f35-b351-b3aa96b0512e

Device Description

Reusable Liquid Crystal Forehead Thermometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	880.2200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62296	Liquid-crystal patient thermometer, reusable	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815236021015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 60 – 104 Degrees Fahrenheit