ManaMed Inc

Basic Information

• Brand Name: ManaMed Inc
• Primary DI: 00810113682532
• Version / Model: ManaEZ Ice Wrap Shoulder
• Catalog Number: EZIWSHLDR01
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-01
• Public Version: 2
• Public Version Date: 2023-11-07
• Public Version Status: Update
• Public Device Record Key: 70e1e497-cbb1-44d7-afa8-cf7af80fa9d3
• Distribution End Date: 2022-10-01

Device Description

ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace also includes an ice pack. Removable ice pack Lightweight, latex free breathable material Effortless application, universal size with hook and loop closure Designed for either left or right shoulder

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: Yes
• 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
KYR	Bag, Ice	General Hospital	880.6050	1
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56283	Shoulder support/thermal therapy bandage	A non-sterile fabric material formed to fit around the shoulder and intended to provide pressure to support the joint following injury (e.g., sports injuries), disease (e.g., rheumatism), and/or surgery; it is designed to accommodate the insertion of a hot/cold pack(s) to provide heat or cold therapy for the skin and underlying tissues to facilitate the reduction of oedema and pain. The device typically includes fasteners; it may be used in a healthcare facility or at home. 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	00810113682532	GS1

Customer Contacts

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