Primary Device ID | 05415067017093 |
NIH Device Record Key | 77d45167-7fcd-4a46-839f-d89e333412d3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prodigy MRI™ |
Version Model Number | 3772 |
Catalog Number | 3772 |
Company DUNS | 149818952 |
Company Name | ST. JUDE MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 |
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 | |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry, and dark place |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067017093 [Primary] |
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
MHY | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-12-01 |
05415067050045 - Neutrino™ | 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
05415067050052 - Gallant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
05415067050076 - Neutrino™ | 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
05415067050090 - Gallant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
05415067050106 - Entrant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
05415067050120 - Entrant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
05415067051844 - Agilis™ NxT Steerable Introducer Dual-Reach™ | 2025-02-17 Steerable Introducer |
05415067051851 - Agilis™ NxT Steerable Introducer Dual-Reach™ | 2025-02-17 Steerable Introducer |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PRODIGY MRI 86325726 4937459 Live/Registered |
Advanced Neuromodulation Systems, Inc. 2014-07-01 |