Identity
- Trade Name
- PlasmaWave Tube Set FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Device Name
- Replacement tube set for the PlasmaWave system. FDA UDI
- Model / Reference
- PW15 FDA UDI
- Description
- Replacement tube set for the PlasmaWave system. FDA UDI
Identifiers
- Catalog Number
- PW15 FDA UDI
- Primary DI / UDI-DI
- 00850998008379 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intermittent venous compression systemExternal cuff/pad connection tubing
PlasmaWave Tube Set 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 43597eeb-0f81-483b-95a3-d4b33796dfdf 35 fields · synced May 30, 2026