SPS-1® (UW Solution)

GUDID 10815045020329

SPS-1® (UW Solution), Static Preservation Solution (2 Liter)

ORGAN RECOVERY SYSTEMS, INC.

Donor-organ preservation solution
Primary Device ID10815045020329
NIH Device Record Key271111dc-a2c7-42f0-9552-4b2a28f7417a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPS-1® (UW Solution)
Version Model NumberSPS-1
Company DUNS078972580
Company NameORGAN RECOVERY SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815045020322 [Primary]
GS110815045020329 [Package]
Contains: 00815045020322
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDLSet, Perfusion, Kidney, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-16

On-Brand Devices [SPS-1® (UW Solution)]

10815045020329SPS-1® (UW Solution), Static Preservation Solution (2 Liter)
10815045020305SPS-1® (UW Solution), Static Preservation Solution (1 Liter)
10815045020282SPS-1® (UW Solution), Static Preservation Solution (500mL)

Trademark Results [SPS-1]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPS-1
SPS-1
77536117 3700841 Live/Registered
Lifeline Scientific, Inc.
2008-07-31

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