E.M Adams co, inc.

Basic Information

• Brand Name: E.M Adams co, inc.
• Primary DI: 18100013404808
• Version / Model: 3073-1
• Company Name: E.M. ADAMS, INC.
• Labeler DUNS: 001403807
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-31
• Public Version: 3
• Public Version Date: 2021-03-01
• Public Version Status: Update
• Public Device Record Key: 2ef53e66-a36b-4449-ac09-68e383a9efac
• Distribution End Date: 2021-02-28

Device Description

HEEL & ELBOW PROTECTOR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42501	Heel protector	A device that is designed to be worn over the foot to provide a cushion to protect the heel from friction against surfaces and knocks against objects; the toes will protrude and not be protected. It is typically made from soft padded materials and is held in place with bands or straps around the foot or the foot can be slid into it like a sock. It is typically used by persons that have tendencies for skin sores on their heels, are bedridden, or prone to lack of control with their legs causing injury to the heels. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	58100013404790	GS1	CASE	48	Not in Commercial Distribution	2021-02-28
Primary	18100013404808	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			12" X 7" BODY/1" X 7" LOOP