Identity
- Trade Name
- ManaCold Platinum Back Pad 2.0 FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
- Device Name
- ManaCold Platinum 2.0 Back 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 FDA UDI
- Model / Reference
- MCOLDPAD02-BACK FDA UDI
- Description
- ManaCold Platinum 2.0 Back 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 FDA UDI
Identifiers
- Catalog Number
- MCOLDPAD02-BACK FDA UDI
- Primary DI / UDI-DI
- 00810113683454 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Circulating-fluid localized thermal therapy system pack, reusable
ManaCold Platinum Back Pad 2.0 by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 39d11bc6-7892-4e6f-addb-dd4eff5e72c5 35 fields · synced Jun 8, 2026