Organ Care System

Primary DI
B00953973
Brand
Organ Care System
Company
TRANSMEDICS, INC.
Model
1404
Catalog number
1404
Device description
OCS Data Card
Published
2021-12-01
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
QIKOrgan Care System (Ocs) Heart System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIKOrgan Care System (Ocs) Heart SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180051000Organ Care System (OCS) Heart SystemTransMedics, Inc.2021-09-03QIK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00953975PackageHIBCC1In Commercial Distribution
B00953973PrimaryHIBCC0

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
978-552-0900xx@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
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
B00913390OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00913600OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00918043OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00924420OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00925721OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00925741OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00925751OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00926340OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00936363OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00936463OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00943661OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00948225OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00948913OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00949290OCS Heart SystemTRANSMEDICS, INC.QIK2021-12-01
B00953975Organ Care SystemTRANSMEDICS, INC.QIK2021-12-01