Waters IGL Pulsatile Perfusion Solution

FDA UDI

Class II (US FDA UDI)

by Preservation Solutions, Inc.

Identity

Trade Name: Waters IGL Pulsatile Perfusion Solution FDA UDI
Generic Name: Donor-organ/tissue/cell preservation solution FDA UDI
Device Name: Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL FDA UDI
Model / Reference: PPS/1000/US FDA UDI
Description: Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL FDA UDI

Identifiers

Primary DI / UDI-DI: 00810805000170 FDA UDI
510(k) Number: K080432 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1000 Milliliter FDA UDI

Category: Donor-organ/tissue/cell preservation solution

Waters IGL Pulsatile Perfusion Solution by Preservation Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K080432 also covers:

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: Preservation Solutions, Inc.

Sources (1)

FDA UDI e01a802a-6a4c-4d5a-84f5-06cbfd1c4ad0 36 fields · synced May 30, 2026