FDA.reportPublic FDA data

OCS Lung System

Primary DI
B00944670
Brand
OCS Lung System
Company
TRANSMEDICS, INC.
Model
2300
Catalog number
2300
Device description
OCS Lung Solution
Published
2018-06-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSBSystem And Accessories, Isolated Heart, Transport And Preservation
QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSBSystem And Accessories, Isolated Heart, Transport And PreservationGastroenterology, Urology2
QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To TransplantationUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00944671PackageHIBCC4In Commercial Distribution
B00944670PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ/tissue/cell preservation solutionA solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.5Inch
Length14Inch
Width5.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9785520900xx@xx.xx

Regulatory Flags#

DUNS number
084445043
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B00962623OCS HEART LEUKOCYTE DEPLETING FILTER146614662026-05-04
B00958753OCS Lung Donor Flush Set240624062023-06-13
B00958755OCS Lung Donor Flush Set240624062023-06-13
B00912500Organ Care System140814082018-06-01
B00950840Organ Care System140814082018-06-01
B00950770OCS Liver System344034402021-12-01
B00926340OCS Heart System130013002021-12-01
B00953973Organ Care System140414042021-12-01
B00953983Organ Care System140414042018-06-01
B00944705OCS Liver System320032002021-12-01
B00944823OCS Liver System340034002021-12-01
B00944833OCS Liver System340134012021-12-01
B00944843OCS Liver System342134212021-12-01
B00946640OCS Liver System340634062021-12-01
B00946650OCS Liver System340634062021-12-01
B00948883OCS Liver System345734572021-12-01
B00950421OCS Liver System345034502021-12-01
B00950480OCS Liver System300030002021-12-01
B00913390OCS Heart System141014102021-12-01
B00913600OCS Heart System140614062021-12-01

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
13700911900126CELSIOR Cold Storage SolutionINSTITUT GEORGES LOPEZMSB2022-02-07
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
B00925731Organ Care SystemTRANSMEDICS, INC.QBA2018-06-12
B00925733Organ Care SystemTRANSMEDICS, INC.QBA2018-06-12
B00912500Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01