gudid
Primary ID: MANACOLD02-PT
ManaCold Platinum Unit 2.0 (UDI MANACOLD02-PT)
Manufactured by Manamed, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ManaCold Platinum Unit 2.0 - Primary ID MANACOLD02-PT
Device Regulatory Overview
The ManaCold Platinum Unit 2.0 (Model/Catalog Number: MANACOLD02-PT) is a medical device manufactured by Manamed, Inc.. This product is indexed under FDA Product Code / Category Classification ILO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- MANACOLD02-PT
- Product Code / EMDN
- ILO
- Device Name
- ManaCold Platinum 2.0 Unit is a water-circulating therapy 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 a leak free transport in the home or clinical setting.Features:Contains a leak free cooling reservoir and 7' insulation tubeIncludes 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 settingFeatures a leak-proof lid and our most secure connectorsHand control for customized prescriptionJoint specific pads, all sold separately
- Database Sync Date
- 2026-08-09 09:12:28
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ManaCold Platinum Unit 2.0?
The registered manufacturer of record for ManaCold Platinum Unit 2.0 is Manamed, Inc..
What is the Primary UDI-DI identifier for ManaCold Platinum Unit 2.0?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MANACOLD02-PT.
What classification code is assigned to this device?
This device is registered under product classification code ILO.
Similar Classification Devices (ILO)
Other Devices by Manamed, Inc.
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