SPS-1® (UW Solution)

FDA UDI

Class II (US FDA UDI)

by Organ Recovery Systems, Inc.

Identity

Trade Name: SPS-1® (UW Solution) FDA UDI
Generic Name: Donor-organ/tissue/cell preservation solution FDA UDI
Device Name: SPS-1® (UW Solution), Static Preservation Solution (2 Liter) FDA UDI
Model / Reference: SPS-1 FDA UDI
Description: SPS-1® (UW Solution), Static Preservation Solution (2 Liter) FDA UDI

Identifiers

Primary DI / UDI-DI: 00815045020322 FDA UDI
510(k) Number: K091656 FDA UDI
FDA Product Code: KDL 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

Yes

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

Category: Donor-organ/tissue/cell preservation solution

SPS-1® (UW Solution) by Organ Recovery Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Donor-organ/tissue/cell preservation solution.

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PARAGON-W (UW solution) — INSTITUT GEORGES LOPEZ · Class II

Cleared under the same submission

K091656 also covers:

SPS-1® (UW Solution) — Organ Recovery Systems, Inc.

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: Organ Recovery Systems, Inc.

Sources (1)

FDA UDI 271111dc-a2c7-42f0-9552-4b2a28f7417a 35 fields · synced Jun 9, 2026