AccessGUDID - DEVICE: Cozyhealth (06975866380020)

GUDID

Device Identifier (DI) Information

Brand Name: Cozyhealth
Version or Model: B09KT8HWDS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chengdu Liangyue Technology Co., Ltd.

Primary DI Number: 06975866380020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 724078743 *Terms of Use

Device Description: No description.

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):	No
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?
41573	Cervical spine cushion	A soft pillow or pad used to provide support and comfort to the user's neck, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to alleviate pressure on the neck and spinal cord while the user is sitting, lying, or standing. This device may function as a cushion under the neck when the user is supine, or it may be placed, even secured, around the user's neck to help support the head.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e8594837-bd26-49f5-9f7f-dcd9e444e9f6
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022