Identity
- Trade Name
- PERFADEX® Plus FDA UDI
- Generic Name
- Donor-organ/tissue/cell preservation solution FDA UDI
- Device Name
- Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 2 x 3000ml FDA UDI
- Model / Reference
- 19950 FDA UDI
- Description
- Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 2 x 3000ml FDA UDI
Identifiers
- Catalog Number
- 19950 FDA UDI
- Primary DI / UDI-DI
- 07350069520296 FDA UDI
- FDA Product Code
- KDN FDA UDI
- GMDN Term
- Donor-organ/tissue/cell preservation solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5880 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Donor-organ/tissue/cell preservation solution
PERFADEX® Plus by Xvivo Perfusion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Donor-organ/tissue/cell preservation solution.
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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
- Xvivo Perfusion, Inc.
Sources (1)
- FDA UDI e74ed705-3c03-496e-a9c0-75849c6f0b68 36 fields · synced Jun 20, 2026