ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680422
• Version / Model: ManaEZ Boot Pediatric - Large
• Catalog Number: EZBPEDL
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-20
• Public Version: 2
• Public Version Date: 2024-07-11
• Public Version Status: Update
• Public Device Record Key: 95757656-4afe-4ef5-9637-6d59410de16b

Device Description

The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and are to be worn to help stabilize the foot and ankle after an injury or surgery. ManaEZ Boot Pediatric boots are color coded for an easy size selection. Small: Pink Medium: Yellow Large: Teal Features and Benefits: Rocker bottom to stimulate natural gait Low profile; lightweight Anatomically-shaped plastic uprights to help facilitate a secure fit for children Easy to apply and adjust with a simple strapping and liner system Fits right and left Ideal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITW	Joint, Ankle, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10667	Cast boot	A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113680422	GS1

Customer Contacts

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