OCS Liver System

Primary DI
B00946650
Brand
OCS Liver System
Company
TRANSMEDICS, INC.
Model
3406
Catalog number
3406
Device description
OCS Liver Gas Cylinder, Refill
Published
2021-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To TransplantationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200031000Organ Care System (OCS™) LiverTransMedics, Inc.2021-09-28QQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00946653PackageHIBCC2In Commercial Distribution
B00946650PrimaryHIBCC0

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 Temperature10 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00DO NOT STORE NEAR HEAT OR AN OPEN FLAME
Special Storage Condition, Specify00STORE WITH ADEQUATE VENTILATION

Contacts#

Phone, Email table
PhoneEmail
978-552-0900xx@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
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
16945630123075Sterilance Soft Lancet 26GSterilance Medical (Suzhou) Inc.QQK2024-01-15
36945630123079Sterilance Soft Lancet 26GSterilance Medical (Suzhou) Inc.QQK2024-01-15
05060462240029OrganOx metraORGANOX LIMITEDQQK2023-02-20
05060462240005OrganOx metraORGANOX LIMITEDQQK2022-06-15
05060462240043metra Liver Perfusion Circuit Pack ORGANOX LIMITEDQQK2022-06-15
B00944705OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944823OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944833OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944843OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00946640OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00948883OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00950421OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00950480OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00950770OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944707OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944895OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944905OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00944915OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00946643OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00946653OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00948895OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00950443OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00950491OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01
B00949381OCS Liver SystemTRANSMEDICS, INC.QQK2021-12-01