FDA.reportPublic FDA data

CELSIOR Cold Storage Solution

Primary DI
13700911900126
Brand
CELSIOR Cold Storage Solution
Company
INSTITUT GEORGES LOPEZ
Model
CELSIOR 1L US
Catalog number
533682
Device description
Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.
Published
2022-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MSBSystem And Accessories, Isolated Heart, Transport And Preservation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSBSystem And Accessories, Isolated Heart, Transport And PreservationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23700911900123PackageGS14In Commercial Distribution
13700911900126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2370091190012323700911900123
1370091190012613700911900126

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ preservation solutionA sterile solution intended to be used in conjunction with a donor-organ preservation/transport set for the flushing, transport, storage and preservation of donor organs (e.g., kidney, liver, heart, and pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain organ viability until the organ can be implanted in the recipient; the solution may be combined with blood. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
393146183
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700911901000Perfusion CannulaPCAN32026-05-11
13700911901017Perfusion CannulaPCAN52026-05-11
13700911901024Perfusion CannulaPCAN82026-05-11
13700911901055Perfusion CouplerPCO252025-05-26
13700911900577DCX Disposable CassetteDCX2025-05-26
23700911901052Perfusion CouplerPCO252025-05-26
13700911900928Perfusion Clamp with AdaptorPC1020A2024-10-18
13700911900935Perfusion Clamp with AdaptorPC715A2024-10-18
13700911900942Perfusion Clamp with AdaptorPC1025A2024-10-18
23700911900925Perfusion Clamp with AdaptorPC1020A2024-10-18
23700911900932Perfusion Clamp with AdaptorPC715A2024-10-18
23700911900949Perfusion Clamp with AdaptorPC1025A2024-10-18
13700911900652PARAGON-W (UW solution)PRGNX/100052023-12-22
13700911900669PARAGON-W (UW solution)PRGNX/100062023-12-22
23700911900659PARAGON-W (UW solution)PRGNX/100052023-12-22
23700911900666PARAGON-W (UW solution)PRGNX/100062023-12-22
13700911900522BEL-GEN Cold Storage SolutionBEL-GEN/2000/US2022-07-21
13700911900591Waters IGL Cold Storage SolutionCSS/10002023-05-24
13700911900607Waters IGL Cold Storage SolutionCSS/20002023-05-24
13700911900621Perfusion ClampPC10202023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052742104401Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104418Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104425Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104456Servator C SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
40331330005006CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
00850005470649SherpaPak Cardiac Transport System (CTS)Paragonix Technologies IncMSB2025-05-05
04033133420007Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2023-07-03
B00958753OCS Lung Donor Flush SetTRANSMEDICS, INC.MSB2023-06-13
B00958755OCS Lung Donor Flush SetTRANSMEDICS, INC.MSB2023-06-13
00851983008060Servator HGLOBAL TRANSPLANT SOLUTIONS, INC.MSB2020-04-21
04033133611016Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-08-08
04033133105003Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
04033133250000Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
04033133610002Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
00869582000316Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
10850005470271Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
10869582000313Paragonix SherpaPak Cardiac Transport SystemPARAGONIX TECHNOLOGIES INCMSB2019-02-15
00869582000323Paragonix SherpaPak Cardiac Transport SystemPARAGONIX TECHNOLOGIES INCMSB2019-02-15
00869582000330Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000347Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000354Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000361Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000378Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000385Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
B00944670OCS Lung SystemTRANSMEDICS, INC.MSB2018-06-01
40331330610002CustodiolDr. Franz Köhler Chemie GmbHMSB2016-09-22