Primary Device ID | 07640135140429 |
NIH Device Record Key | 69a3bd97-4495-4619-b92f-6289bc690a9c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CentriMag™ |
Version Model Number | 201-50129 |
Catalog Number | 201-50129 |
Company DUNS | 486066918 |
Company Name | Thoratec Switzerland GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640135140429 [Primary] |
KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-06 |
Device Publish Date | 2022-03-29 |
07640135140566 | USB Stick containing Mag Log Converter Software |
07640135140481 | Pressure Cable for Argon Medical CDX III Pressure Transducers |
07640135140443 | Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 Pressure Sensors |
07640135140436 | Pressure Cable for Smiths Medical LogiCal Plus Pressure Sensors |
07640135140429 | Pressure Cable for Smiths Medical TranStar Pressure Sensors |
07640135140412 | Pressure Cable for Bbraun Combitrans Pressure Transducers |
07640135140283 | Centrimag Motor Bracket (45 degree) |
07640135140276 | Pressure Cable for BD DTX Plus Transducer |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CENTRIMAG 87581813 5915360 Live/Registered |
Thoratec, LLC 2017-08-24 |
CENTRIMAG 87212973 5231717 Live/Registered |
Thoratec LLC 2016-10-24 |
CENTRIMAG 76257306 2599358 Live/Registered |
THORATEC LLC 2001-05-15 |