Crystaline W 5105SB

GUDID 10815236020237

Crystaline W Liquid Crystal Temperature Trend Indicator

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 10815236020237
• NIH Device Record Key: 7910fa39-8a59-45bc-adb9-26bb5529a830
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crystaline W
• Version Model Number: 5105SB
• Catalog Number: 5105SB
• Company DUNS: 059247507
• Company Name: LCR HALLCREST, LLC.
• Device Count: 2
• 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: 1-800-325-3671
• Email: mailbox@sharn.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236020230 [Unit of Use]
GS1	10815236020237 [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: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-23

On-Brand Devices [Crystaline W]

• 10815236020237: Crystaline W Liquid Crystal Temperature Trend Indicator
• 20815236020227: Crystaline W Liquid Crystal Temperature Trend Indicator
• 10815236020213: Crystaline W Liquid Crystal Temperature Trend Indicator