Identity
- Trade Name
- Waters IGL Cold Storage Solution FDA UDI
- Generic Name
- Donor-organ/tissue/cell preservation solution FDA UDI
- Device Name
- Formulated for flushing and cold storage of kidney, liver and pancreas organs. 2000 mL FDA UDI
- Model / Reference
- CSS/2000/US FDA UDI
- Description
- Formulated for flushing and cold storage of kidney, liver and pancreas organs. 2000 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810805000163 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
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
Dimensions & Sizes
- Size
- Total Volume — 2000 Milliliter FDA UDI
Category: Donor-organ/tissue/cell preservation solution
Waters IGL Cold Storage Solution by Preservation Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Donor-organ/tissue/cell preservation solution.
- Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
- Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
- Custodiol — Dr. Franz Köhler Chemie GmbH · Class II
- X°Port Lung Preservation Solution — Traferox Technologies, Inc. · Class II
- STEEN Solution™ — XVIVO PERFUSION, INC. · Class III
- Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
- PARAGON-W (UW solution) — INSTITUT GEORGES LOPEZ · Class II
- X°Port Lung Preservation Solution — Traferox Technologies, Inc. · Class II
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
- Preservation Solutions, Inc.
Sources (1)
- FDA UDI a71ab6a7-77b7-4946-b44c-a3951a2b5669 35 fields · synced Jun 8, 2026