Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system FDA UDI
- Device Name
- ManaCold Platinum Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting FDA UDI
- Model / Reference
- ManaCold Platinum Univeral Combo Unit FDA UDI
- Description
- ManaCold Platinum Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting FDA UDI
Identifiers
- Catalog Number
- MANACOLD01-PT FDA UDI
- Primary DI / UDI-DI
- 00810113682594 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ManaMed by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 39e7d506-9d1a-4847-a3a9-213b5d1d0adf 36 fields · synced Jun 8, 2026