Identity
- Trade Name
- PXP-LAVARE FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Device Name
- PXP-LAVARE Disposable Cartridge FDA UDI
- Model / Reference
- 80118 FDA UDI
- Description
- PXP-LAVARE Disposable Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886368000193 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Blood centrifugation system containment kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Blood centrifugation system containment kit
Pxp-Lavare by Thermogenesis Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK120061 also covers:
- PXP — Thermogenesis Corp.
- PXP — Thermogenesis Corp.
- PXP — Thermogenesis Corp.
- PXP — Thermogenesis Corp.
- PXP — Thermogenesis Corp.
- PXP — Thermogenesis Corp.
- PXP-1000 — Thermogenesis Corp.
- PXP-1000 — Thermogenesis Corp.
- PXP-1000 — Thermogenesis Corp.
- PXP-1000 — Thermogenesis Corp.
- PXP-1000 — Thermogenesis Corp.
- PXP-1000 Docking Station — Thermogenesis Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermogenesis Corp.
Sources (1)
- FDA UDI c58c0af6-d27b-4c42-b689-3bd466371856 36 fields · synced May 30, 2026