ClearMate

GUDID 18071411282223

ClearMate TM is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate TM enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.

Thornhill Research Inc

Oxygen/air breathing gas mixer, emergency

• Primary Device ID: 18071411282223
• NIH Device Record Key: d5b438bf-015d-4568-abee-7a38badd2be0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearMate
• Version Model Number: 128222
• Company DUNS: 205151975
• Company Name: Thornhill Research Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-416-597-1325
• Email: info@thornhillmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18071411282001 [Package]; Package: System Kit [1 Units]; In Commercial Distribution
GS1	18071411282223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170044

FDA Product Code

• QFB: Isocapnic Ventilation Device

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: 2019-06-17
• Device Publish Date: 2019-06-07

On-Brand Devices [ClearMate]

• 18071411282223: ClearMate TM is intended to be used by emergency department medical professionals as an adjunct
• 10807141000107: Assy, ClearMate, DISS, US