AccessGUDID - DEVICE: CVS Health (00050428396087)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health
Version or Model: 894776
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428396087
Issuing Agency: GS1
Commercial Distribution End Date: June 18, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: CVS Health Plantar Fasciitis Gel Arch Sleeves

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?
11095	Foot cushion	A soft pillow or pad used to provide support and comfort to the user's feet, often during the treatment and/or prevention of musculoskeletal or circulatory disorders. The device may simply be used to alleviate pressure on the heels while the patient is sitting, or to slightly elevate the feet to reduce pressure and improve blood circulation in the lower extremity for the prevention of pressure sores and ulcers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: ee1b3963-db40-495e-b71f-9ac9444621dd
Public Version Date: June 18, 2024
Public Version Number: 2
DI Record Publish Date: June 18, 2020