OCS Lung System

Primary DI
B00939180
Brand
OCS Lung System
Company
TRANSMEDICS, INC.
Model
2461
Catalog number
2461
Device description
OCS Lung Monitoring Gas Cylinder, Refill
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B00939183PackageHIBCC2In Commercial Distribution
B00939180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ preservation/transport system gas refillable cylinderA portable container designed as a refillable cylinder to hold a custom gas mixture for use in a donor-organ (e.g., kidney, lung, liver, heart) preservation/transport system. It is typically made of aluminium and fibre glass; the contained gas is typically a custom mix of oxygen, carbon dioxide, and nitrogen used for preservation and/or evaluation of the extracorporeal organ. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Length18Inch
Width4Inch

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
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

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
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
B00953983Organ 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