Iperia 7 VR-T
- Primary DI
- 04035479129507
- Brand
- Iperia 7 VR-T
- Company
- BIOTRONIK SE & Co. KG
- Model
- 393035
- Catalog number
- 393035
- Published
- 2015-02-18
- 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 |
|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Unknown | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04035479129507 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Single-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. 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 one heart chamber (typically a ventricle) to monitor the ECG and to automatically deliver the electrical impulse to treat ventricular fibrillation or tachycardia. The device has internal batteries that provide the energy to deliver the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD). |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 41 Degrees Fahrenheit | 113 Degrees Fahrenheit | |
Contacts
| Phone | Email |
|---|
| +1(888)345-0374 | jon.brumbaugh@biotronik.com |
Regulatory Flags
- DUNS number
- 315620229
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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