Crystaline® Moving Line 5101C-MLC

GUDID 20815236020173

Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 100

LCR HALLCREST, LLC.

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• Primary Device ID: 20815236020173
• NIH Device Record Key: 5679c71e-8919-4447-ab88-6936356f1bf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crystaline® Moving Line
• Version Model Number: 5101C-MLC
• Catalog Number: 5101C-MLC
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com
• Phone: 1-800-328-3671
• Email: mailbox@sharn.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236020179 [Unit of Use]
GS1	10815236020176 [Primary]
GS1	20815236020173 [Package]; Contains: 10815236020176; Package: Case [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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [Crystaline® Moving Line]

• 00815236020209: Crystaline Temperature Trend Indicators
• 20815236020197: Crystaline Temperature Trend Indicators Sample Dispenser
• 20815236020180: Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 50
• 20815236020173: Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 100