QUADRA ASSURA MP™
- Primary DI
- 05414734508377
- Brand
- QUADRA ASSURA MP™
- Company
- ST. JUDE MEDICAL, INC.
- Model
- CD3369-40Q
- Catalog number
- CD3369-40Q
- Device description
- Cardiac resynchronization device tiered therapy cardioverter/defibrillator VVED DDDRV
- Published
- 2016-03-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | Unknown | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05414734508377 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05414734508377 | 05414734508377 | 5414734508377 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac resynchronization therapy implantable defibrillator | A sterile, implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)]. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | -20 Degrees Celsius | 60 Degrees Celsius | |
| Handling Environment Temperature | -4 Degrees Fahrenheit | 140 Degrees Fahrenheit | |
| Special Storage Condition, Specify | 0 | 0 | Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference. |
| Special Storage Condition, Specify | 0 | 0 | Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | 10 Degrees Celsius | 45 Degrees Celsius | |
| Storage Environment Temperature | 22 Degrees Celsius | 22 Degrees Celsius | |
| Storage Environment Temperature | 50 Degrees Fahrenheit | 113 Degrees Fahrenheit | |
| Storage Environment Temperature | 72 Degrees Fahrenheit | 72 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 790268031
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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