AccessGUDID - DEVICE: Q-Collar (00850038401023)

GUDID

Device Identifier (DI) Information

Brand Name: Q-Collar
Version or Model: 204916-13
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Q30 Sports Science, LLC

Primary DI Number: 00850038401023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089344877 *Terms of Use

Device Description: Q-Collar, First Generation, Green/Black, Size 13

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNX	External Compression Device For Internal Jugular Vein Compression

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200017	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ffb0ff2d-fa69-4bf7-be1c-833f78573d98
Public Version Date: November 02, 2023
Public Version Number: 1
DI Record Publish Date: October 25, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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