Identity
- Trade Name
- ManaFlow 52 FDA UDI
- Generic Name
- Intermittent venous compression system pump FDA UDI
- Device Name
- The ManaFlow system, part number MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. 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
- MFLOW52 FDA UDI
- Description
- The ManaFlow system, part number MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. 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
- MFLOW52 FDA UDI
- Primary DI / UDI-DI
- 00850998008898 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Intermittent venous compression system pump 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: Intermittent venous compression system pump
ManaFlow 52 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 2b5c571d-2735-47af-a3fe-ec302a658598 34 fields · synced Jun 8, 2026