Organ Care System

Primary DI
B00953983
Brand
Organ Care System
Company
TRANSMEDICS, INC.
Model
1404
Catalog number
1404
Device description
OCS Data Card
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To TransplantationUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00953985PackageHIBCC1In Commercial Distribution
B00953983PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Data storage cardA small electronic device designed to connect to a dedicated port of a computer, typically called a card slot, to download or upload saved data. Commonly known as a memory card or PC card, it is made of metal and plastic materials and typically has flat metal segmented contact points at one end to connect to computerized devices.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.08Inch
Length1Inch
Width1.25Inch

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

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
B00944670OCS Lung System230023002018-06-01
B00950770OCS Liver System344034402021-12-01
B00926340OCS Heart System130013002021-12-01
B00953973Organ Care System140414042021-12-01
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
B00925731Organ Care SystemTRANSMEDICS, INC.QBA2018-06-12
B00925733Organ Care SystemTRANSMEDICS, INC.QBA2018-06-12
B00912500Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00913320Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00914051Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00925681Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00928590OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00928600OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00937641OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939111OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939170OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939180OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939240OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939251OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939270Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00940001OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00944670OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00950840Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00912501Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00925711Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00954033Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00954003Organ Care SystemTRANSMEDICS, INC.QBA2018-06-01
B00928593OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00928603OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00937663OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00938535OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00937673OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939173OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939183OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01
B00939231OCS Lung SystemTRANSMEDICS, INC.QBA2018-06-01