ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680675
• Version / Model: ManaEZ Shoulder Ice
• Catalog Number: EZSHLD
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-21
• Public Version: 1
• Public Version Date: 2022-06-29
• Public Version Status: New
• Public Device Record Key: d0bda748-aab2-4821-acdb-1ced23e74d6c

Device Description

The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint. Pump up with air and compress the cold to alleviate pain faster. Removable gel liner for cooling in freezer. Drip free fabric to allow breathing. Easy to apply over clothing. Can be used for sprains, sports injuries, rehab, arthritis, and muscle tensions / fatigues.

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
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
37240	Hot/cold therapy pack, reusable	A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.	No	Active
12101	Shoulder immobilizer/orthosis, reusable	A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113680675	GS1

Customer Contacts

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