DermaTherm SSH2100PB-SB

GUDID 10815236020008

Sharn temperature indicators read and display skin temperature. Use these indicators in your Pain Management Department to diagnose RSD, as well as to assess the effectiveness of nerve blocks within minutes by watching for a sympathetic rise in temperature. They are also useful when doing EMGs.

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 10815236020008
• NIH Device Record Key: 5b9324ff-bd87-4bea-b29a-6569d1d154cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaTherm
• Version Model Number: 2100PB-SB
• Catalog Number: SSH2100PB-SB
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236020008 [Unit of Use]
GS1	10815236020008 [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: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-23

On-Brand Devices [DermaTherm]

• 10815236020077: Sharn temperature indicators read and display skin temperature. Use these indicators in your Pai
• 10815236020060: Sharn temperature indicators read and display skin temperature. Use these indicators in your Pai
• 10815236020053: Sharn temperature indicators read and display skin temperature. Use these indicators in your Pai
• 10815236020046: 2100PB
• 10815236020039: Sharn temperature indicators read and display skin temperature. Use these indicators in your Pai
• 10815236020008: Sharn temperature indicators read and display skin temperature. Use these indicators in your Pai