Q-Collar

Primary DI
00850038401115
Brand
Q-Collar
Company
Q30 Sports Science, LLC
Model
205071-14
Device description
Q-Collar, Tactical, Blackout, Size 14
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QNXExternal Compression Device For Internal Jugular Vein Compression

Product Code Classifications

CodeDeviceSpecialtyClass
QNXExternal Compression Device For Internal Jugular Vein CompressionNeurology2

Premarket Submissions

SubmissionSupplement
DEN200017000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200017000Q-CollarQ30 Sports Science, LLC2021-02-26QNX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850038401115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038401115008500384011158500384011150850038401115

GMDN Terms

TermDefinition
Traumatic brain injury protection compression collarA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
089344877
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850038401320Q-Collar207200-182025-07-21
00850038401337Q-Collar207200-172025-07-21
00850038401344Q-Collar207200-162025-07-21
00850038401351Q-Collar207200-152025-07-21
00850038401368Q-Collar207200-142025-07-21
00850038401375Q-Collar207200-132025-07-21
00850038401382Q-Collar207200-122025-07-21
00850038401399Q-Collar207200-112025-07-21
00850038401085Q-Collar205071-112023-10-26
00850038401092Q-Collar205071-122023-10-26
00850038401108Q-Collar205071-132023-10-26
00850038401122Q-Collar205071-152023-10-26
00850038401139Q-Collar205071-162023-10-26
00850038401146Q-Collar205071-172023-10-26
00850038401153Q-Collar205071-182023-10-26
00850038401160Q-Collar205072-112023-10-26
00850038401177Q-Collar205072-122023-10-26
00850038401184Q-Collar205072-132023-10-26
00850038401191Q-Collar205072-142023-10-26
00850038401207Q-Collar205072-152023-10-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850038401320Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401337Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401344Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401351Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401368Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401375Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401382Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401399Q-CollarQ30 Sports Science, LLCQNX2025-07-21
00850038401085Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401092Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401108Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401122Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401139Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401146Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401153Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401160Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401177Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401184Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401191Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401207Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401214Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401221Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401238Q-CollarQ30 Sports Science, LLCQNX2023-10-26
00850038401009Q-CollarQ30 Sports Science, LLCQNX2023-10-25
00850038401016Q-CollarQ30 Sports Science, LLCQNX2023-10-25
00850038401023Q-CollarQ30 Sports Science, LLCQNX2023-10-25
00850038401030Q-CollarQ30 Sports Science, LLCQNX2023-10-25
00850038401047Q-CollarQ30 Sports Science, LLCQNX2023-10-25
00850038401054Q-CollarQ30 Sports Science, LLCQNX2023-10-25
00850038401061Q-CollarQ30 Sports Science, LLCQNX2023-10-25