Identity
- Trade Name
- ManaFlow 52 FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- The ManaFlow system, part number MFLOW52LEG, is comprised of a full leg gradient compression sleeve and a portable intermittent pump. The ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: • Treatment of lymphedema • Treatment of chronic venous insufficiency • Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers • Reducing venous leg ulcer healing time • Reducing edema due to venous stasis • Enhancing venous return The device is intended for home, and hospital use. FDA UDI
- Model / Reference
- MFLOW52LEG FDA UDI
- Description
- The ManaFlow system, part number MFLOW52LEG, is comprised of a full leg gradient compression sleeve and a portable intermittent pump. The ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: • Treatment of lymphedema • Treatment of chronic venous insufficiency • Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers • Reducing venous leg ulcer healing time • Reducing edema due to venous stasis • Enhancing venous return The device is intended for home, and hospital use. FDA UDI
Identifiers
- Catalog Number
- MFLOW52LEG FDA UDI
- Primary DI / UDI-DI
- 00810113681511 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Sequential venous compression system inflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sequential venous compression system inflator
ManaFlow 52 by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- TRIPLE PLAY — Compression Solutions, LLC · Class II
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 90bc1e11-a8cc-4926-9783-c1172ceb1afc 34 fields · synced Jun 6, 2026