OCS Heart System 1425

GUDID B00925741

Coronary Flow Probe

TRANSMEDICS, INC.

Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe Extracorporeal fluid flow probe
Primary Device IDB00925741
NIH Device Record Keyb3be27ff-95ed-4c08-a370-df033f58b023
Commercial Distribution StatusIn Commercial Distribution
Brand NameOCS Heart System
Version Model Number1425
Catalog Number1425
Company DUNS084445043
Company NameTRANSMEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx

Device Dimensions

Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch
Length9 Inch
Width5.13 Inch
Height2.3 Inch

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB00925741 [Primary]
HIBCCB00925743 [Package]
Package: Cardboard Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIKOrgan Care System (Ocs) Heart System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-09
Device Publish Date2021-12-01

On-Brand Devices [OCS Heart System]

B00949290OCS Heart Console
B00948913OCS Heart Solution Line Set
B00948225OCS Heart Perfusion Set
B00943661Cable Tie Tool, Small Diameter
B00936463OCS Cardioplegic Arrest Set
B00936363OCS Heart Instrumentation Tool Set
B00926340OCS Heart Solution Set
B00925751SvO2/HCT Probe
B00925741Coronary Flow Probe
B00925721Aortic Flow Probe
B00924420OCS Heart Gas Cylinder, Refill
B00918043OCS Blood Collection Set
B00913600OCS Heart Gas Cylinder
B00913390OCS Wireless Monitor, Heart

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.