QUADRA ALLURE MP™ PM3160
GUDID 05414734509084
Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV
ST. JUDE MEDICAL, INC.
Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker| Primary Device ID | 05414734509084 |
| NIH Device Record Key | 8aee4531-fd1c-4a80-91a9-dae71122ffca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUADRA ALLURE MP™ |
| Version Model Number | PM3160 |
| Catalog Number | PM3160 |
| Company DUNS | 790268031 |
| 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 | true |
| 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 | |
| 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 |
Device Dimensions
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734509084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030035
FDA Product Code
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-23 |
On-Brand Devices [QUADRA ALLURE MP™]
| 05414734510097 | Cardiac resynchronization therapy device, pulse generator DDDRV |
| 05414734509091 | Cardiac resynchronization therapy device, pulse generator DDDRV |
| 05414734509084 | Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV |
Trademark Results [QUADRA ALLURE MP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUADRA ALLURE MP 85761053 4748350 Live/Registered |
Pacesetter, Inc. 2012-10-23 |
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