Identity
- Trade Name
- Servator H FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient. FDA UDI
- Model / Reference
- GTS-SERV-HTK-5000 FDA UDI
- Description
- Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851983008060 FDA UDI
- FDA Product Code
- MSB FDA UDI
- GMDN Term
- Kidney donor-organ preservation/transport perfusion set 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
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
Yes
FDA UDI
Category: Kidney donor-organ preservation/transport perfusion set
Servator H by Global Transplant Solutions, Inc. — 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
- Global Transplant Solutions, Inc.
Sources (1)
- FDA UDI 23cf87e6-e291-4ba3-ac86-33c14a011d76 34 fields · synced May 30, 2026