ManaMed Inc

Basic Information

• Brand Name: ManaMed Inc
• Primary DI: 00810113682679
• Version / Model: ManaCold Platinum Hip Pad
• Catalog Number: MCOLDPAD-HIP
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-28
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 89704ad7-bd86-452c-9033-e8d36d188f4c

Device Description

ManaCold Platinum Hip Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold therapy hip pad is applied to a patient's injured area, delivering cold therapy through the ManaCold tubing and into the cold pad. ManaCold Platinum Hip Pad can be used and operated by a patient or healthcare provider in a home or clinical setting

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: 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
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	00810113682679	GS1

Customer Contacts

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