CentriMag™ CM2TR00
GUDID 05415067042439
System Transporter
Thoratec Corporation
Electromechanical device/system transport trolley| Primary Device ID | 05415067042439 |
| NIH Device Record Key | bde5ed57-ea2c-4f7c-9be3-fa51ea240e12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CentriMag™ |
| Version Model Number | CM2TR00 |
| Catalog Number | CM2TR00 |
| Company DUNS | 070156955 |
| Company Name | Thoratec Corporation |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 | |
| 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 0.45kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
| Special Storage Condition, Specify | Between 0 and 0 *In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067042439 [Primary] |
FDA Product Code
| KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-07 |
| Device Publish Date | 2022-08-30 |
Devices Manufactured by Thoratec Corporation
| 15415067038279 - HeartMate™ | 2022-09-20 ICU Cover |
| 05415067042439 - CentriMag™ | 2022-09-07System Transporter |
| 05415067042439 - CentriMag™ | 2022-09-07 System Transporter |
| 05415067038760 - HeartMate 3™ | 2022-06-22 Coring Tool |
| 05415067039286 - HeartMate 3™ | 2022-06-22 Apical Cuff |
| 05415067039361 - HeartMate 3™ | 2022-06-22 Skin Coring Punch |
| 15415067039481 - HeartMate 3™ | 2022-06-22 Thread Protectors |
| 05415067033758 - HeartMate Touch™ | 2020-07-02 Communication System |
| 05415067032058 - HeartMate Touch™ | 2020-05-12 Communication System |
Trademark Results [CentriMag]
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 |
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