AccessGUDID - DEVICE: Avaline Medical NJ LLC (00810077210192)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: vkfhp01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: vkfhp01
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00810077210192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 079767953 *Terms of Use
Previous DI: 00667605027896

Device Description: Foam Heel Protectors

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?
32858	Elbow/ankle friction/impact protector	A device designed to be worn over the elbow and/or the ankle to provide a cushion to protect the joint(s) from friction against surfaces and knocks against objects. It is typically made from soft padded materials and held in place with straps; it is designed to cover only the joint(s) and is not intended to cover a larger portion of the arm or leg. It is typically used by persons that have tendencies for skin sores on their elbows, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.	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: cafc2dbd-c1c9-4912-8cdb-7ef88fe62e24
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: October 15, 2021