Q-Collar

Basic Information

• Brand Name: Q-Collar
• Primary DI: 00850038401191
• Version / Model: 205072-14
• Company Name: Q30 Sports Science, LLC
• Labeler DUNS: 089344877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-26
• Public Version: 1
• Public Version Date: 2023-11-03
• Public Version Status: New
• Public Device Record Key: b0af6ce7-0a21-4885-a3e0-0129423f8e8e

Device Description

Q-Collar, Tactical, MultiCam, Size 14

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNX	External Compression Device For Internal Jugular Vein Compression	Neurology	890.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66868	Traumatic brain injury protection compression collar	A device designed to be worn around the neck during impact-prone activities (e.g., sports, military) to restrict brain movement [slosh] inside the skull, by slightly compressing the jugular veins and subsequently increasing blood volume in the skull, for protection against the potentially damaging effects of repetitive sub-concussion head impacts. A fitting-size verification tool and carrying case may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038401191	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN200017	000