ManaCold Platinum Shoulder Pad 2.0 MANACOLD02-SHLD

GUDID 00810113683423

ManaCold Platinum 2.0 Shoulder 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

Manamed, Inc.

Circulating-fluid localized thermal therapy system pack, reusable

• Primary Device ID: 00810113683423
• NIH Device Record Key: 58085b8a-9e43-4957-a0b5-1291f948de80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManaCold Platinum Shoulder Pad 2.0
• Version Model Number: MANACOLD02-SHLD
• Catalog Number: MANACOLD02-SHLD
• Company DUNS: 084042331
• Company Name: Manamed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113683423 [Primary]

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-22
• Device Publish Date: 2025-09-12

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