Identity
- Trade Name
- X°Port Lung Preservation System FDA UDI
- Generic Name
- General-purpose donor-organ preservation/transport system FDA UDI
- Device Name
- Lung Preservation System FDA UDI
- Model / Reference
- 909-0011 FDA UDI
- Description
- Lung Preservation System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540161670153 FDA UDI
- 510(k) Number
- K243870 FDA UDI
- FDA Product Code
- KDN FDA UDI
- GMDN Term
- General-purpose donor-organ preservation/transport system 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose donor-organ preservation/transport system
X°Port Lung Preservation System by Traferox Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Traferox Technologies, Inc.
Sources (1)
- FDA UDI e8015ee3-fdf4-415e-891f-e9f4736229c7 34 fields · synced May 30, 2026