FDA.reportPublic FDA data

OCS Lung Donor Flush Set

Primary DI
B00958753
Brand
OCS Lung Donor Flush Set
Company
TRANSMEDICS, INC.
Model
2406
Catalog number
2406
Device description
OCS Lung Donor Flush Set
Published
2023-06-13
Public version status
New
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

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
B00958755PackageHIBCC1In Commercial Distribution
B00958753PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ preservation/transport perfusion initiation/termination setA collection of sterile devices intended to be used for the initiation and/or termination of perfusion of an organ in an donor-organ preservation/transport system. It includes tubing, tube clamps and may in addition include bags, connectors/adaptors, and filters. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Length18Inch
Width12Inch

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
9784947494xzhuang@transmedics.com

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
B00958755OCS Lung Donor Flush Set240624062023-06-13
B00912500Organ Care System140814082018-06-01
B00950840Organ Care System140814082018-06-01
B00944670OCS Lung System230023002018-06-01
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
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
B00944670OCS Lung SystemTRANSMEDICS, INC.MSB2018-06-01
40331330610002CustodiolDr. Franz Köhler Chemie GmbHMSB2016-09-22