Identity
- Trade Name
- PlasmaFlow FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Device Name
- The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. FDA UDI
- Model / Reference
- PF0001 FDA UDI
- Description
- The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. FDA UDI
Identifiers
- Catalog Number
- PF0001 FDA UDI
- Primary DI / UDI-DI
- 00850998008003 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Intermittent venous compression system 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
PlasmaFlow 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 43e96cd3-0daa-4abc-ac1c-97d9130ed9c6 35 fields · synced Jun 8, 2026