Identity
- Trade Name
- Perfadex with THAM FDA UDI
- Generic Name
- Donor-organ/tissue/cell preservation solution FDA UDI
- Device Name
- Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 8x 1000 ml FDA UDI
- Model / Reference
- 19017 FDA UDI
- Description
- Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 8x 1000 ml FDA UDI
Identifiers
- Catalog Number
- 19017 FDA UDI
- Primary DI / UDI-DI
- 07350069520050 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
- Not 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
No
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
No
FDA UDI
Perfadex with THAM by Xvivo Perfusion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Xvivo Perfusion, Inc.
Sources (1)
- FDA UDI 39dbe32c-b8a1-45e6-a361-5b9f7fdf431a 37 fields · synced Jun 20, 2026