ClearMate

Basic Information

• Brand Name: ClearMate
• Primary DI: 10807141000107
• Version / Model: 128222
• Company Name: Thornhill Research Inc
• Labeler DUNS: 205151975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-01
• Public Version: 2
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: b76f2017-a3e4-492d-aaca-0e80ab620b1c

Device Description

Assy, ClearMate, DISS, US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
QFB	Isocapnic Ventilation Device	General Hospital	868.5480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62595	Oxygen/air breathing gas mixer, emergency	A portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergency situations. It is a hand-held compact unit designed to be connected to an O2 gas container and includes an O2/air mixing valve, a filter for the removal of exhaled carbon dioxide (CO2), a bag for exhaled gas collection and recycling (rebreathing functionality), and connectors (e.g., for attachment to a breathing mask). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10807141000107	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN170044	000