Evera MRI™ S DR SureScan®
- Primary DI
- 00763000059705
- Brand
- Evera MRI™ S DR SureScan®
- Company
- MEDTRONIC, INC.
- Model
- DDMC3D4
- Device description
- ICD-DR DDMC3D4 EVERA MRI S US IS1/DF4
- Published
- 2017-10-21
- 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 |
|---|
| NVZ | Pulse generator, permanent, implantable |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NVZ | Pulse Generator, Permanent, Implantable | Unknown | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00763000059705 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00763000059705 | 00763000059705 | 763000059705 | 0763000059705 |
GMDN Terms
| Term | Definition |
|---|
| Dual-chamber implantable defibrillator | An implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate and to pace the heart in cases of bradycardia. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on two same-side heart chambers (atrium and ventricle) to monitor the ECG and to automatically deliver the electrical impulse. The device has internal batteries that provide the energy to deliver the impulses; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD). |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 Degrees Fahrenheit | 131 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 006261481
- 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
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 08031527017174 | Smartview | MICROPORT CRM SRL | NVZ | 2017-11-23 |
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