FDA UDI
In Commercial Distribution
🇺🇸 United States
VALITUDE™ X4 CRT-P
DI: 00802526559402
·
Model: U128
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VALITUDE™ X4 CRT-P
- Primary DI
- 00802526559402
- Version / Model
- U128
- Catalog Number
- U128
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 106295384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-11
- Public Version
- 11
- Public Version Date
- 2023-08-22
- Public Version Status
- Update
- Public Device Record Key
- ba184c21-417a-4af1-b76d-0799d5fb5002
Device Description
Cardiac Resynchronization Therapy Pacemaker
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 |
|---|---|---|---|---|
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47263 | Cardiac resynchronization therapy implantable pacemaker | A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00802526559402 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030005 | 113 |
| P030005 | 116 |
| P030005 | 119 |
| P030005 | 129 |
| P030005 | 133 |
| P030005 | 138 |
| P030005 | 156 |
| P030005 | 157 |
| P030005 | 164 |
| P030005 | 176 |
| P030005 | 180 |
| P030005 | 186 |
| P030005 | 201 |
| P030005 | 210 |
| P030005 | 220 |
| P030005 | 223 |
| P030005 | 225 |