ManaCold Platinum Ankle Pad 2.0

Basic Information

• Brand Name: ManaCold Platinum Ankle Pad 2.0
• Primary DI: 00810113683447
• Version / Model: MCOLDPAD02-ANKLE
• Catalog Number: MCOLDPAD02-ANKLE
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-12
• Public Version: 1
• Public Version Date: 2025-09-22
• Public Version Status: New
• Public Device Record Key: b0733abd-d990-4990-ba81-2fddf2caaf2b

Device Description

ManaCold Platinum 2.0 Ankle Pad is a water-circulating pad that's attached to our water-circulation device used to decrease pain, swelling, and muscle spasms after surgery or injury. When the cold therapy pad is applied to the patient's injured area, it delivers continuous cold therapy through the pad. It creates an easy solution for your patients without a large mess. The device has a spill proof design to allow leak free transport in the home or clinical setting. ManaCold Platinum Unit Features: Contains a leak free cooling reservoir and 7' insulation tube Includes a controller to control water flow and usage time. ManaCold Platinum 2.0 can be used and operated by a patient or healthcare provider in a home or clinical setting Features a leak-proof lid and our most secure connectors Hand control for customized prescription Joint specific pads, all sold separately

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32965	Circulating-fluid localized thermal therapy system pack, reusable	A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113683447	GS1

Customer Contacts

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