FDA UDI
In Commercial Distribution
🇺🇸 United States
DYNAGEN™ CRT-D
DI: 00802526534614
·
Model: G150
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DYNAGEN™ CRT-D
- Primary DI
- 00802526534614
- Version / Model
- G150
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 106295384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-06
- Public Version
- 8
- Public Version Date
- 2023-03-31
- Public Version Status
- Update
- Public Device Record Key
- fbc148b1-8ca7-40f5-8e6c-d79e6d17e8cf
Device Description
Cardiac Resynchronization Therapy Defibrillator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47270 | Cardiac resynchronization therapy implantable defibrillator | An 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)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00802526534614 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010012 | 341 |
| P010012 | 355 |
| P010012 | 359 |
| P010012 | 371 |
| P010012 | 376 |
| P010012 | 395 |
| P010012 | 399 |
| P010012 | 405 |
| P010012 | 409 |
| P010012 | 411 |
| P010012 | 427 |
| P010012 | 446 |
| P010012 | 451 |
| P010012 | 453 |
| P010012 | 458 |
| P010012 | 504 |
| P010012 | 506 |
| P010012 | 528 |
| P010012 | 560 |