ManaMed Inc

Basic Information

• Brand Name: ManaMed Inc
• Primary DI: 00810113682600
• Version / Model: ManaEZ Ice Wrist
• Catalog Number: EZIWST01
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-13
• Public Version: 1
• Public Version Date: 2022-10-21
• Public Version Status: New
• Public Device Record Key: 8854657b-cd8c-4529-b0e1-655e4cfe2bd3

Device Description

ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist 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 wrist

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: Yes
• 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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15026	Moist-cold pack	A non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold. It typically consists of a disposable pad/pack/towel that includes an overlapping of several layers of fabric (e.g., gauze, cotton) and is intended to apply moist cold to the tissues after immersion in cold water and freed from excess moisture; it is not a compression bandage. It is typically used for temporary vasoconstriction of superficial blood vessels to help control bleeding, to inhibit inflammation and microbial activity in the early stages of infection, and to prevent/control oedema after strains or contusions. This is a single-use device.	No	Active
12102	Wrist immobilizer, reusable	A rigid support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113682600	GS1

Customer Contacts

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