CentriMag™ CMAEK00
GUDID 05415067036414
PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set Cardiopulmonary bypass system priming set| Primary Device ID | 05415067036414 |
| NIH Device Record Key | 2449552b-858a-4b60-ba36-978996cc4a0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CentriMag™ |
| Version Model Number | CMAEK00 |
| Catalog Number | CMAEK00 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067036414 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222297
FDA Product Code
| DTQ | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-25 |
| Device Publish Date | 2023-05-17 |
Devices Manufactured by ST. JUDE MEDICAL, INC.
| 05415067049414 - Entrant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
| 05415067049421 - Gallant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
| 05415067049469 - Entrant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
| 05415067049476 - Gallant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
| 05415067049513 - Entrant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
| 05415067049520 - Gallant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
| 05415067047700 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047724 - TriClip™ | 2024-04-22 G4 Delivery 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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