FDA UDI
In Commercial Distribution
🇺🇸 United States
Gallant™
DI: 05415067050090
·
Model: CDHFA500B
·
ST. JUDE MEDICAL, INC.
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Gallant™
- Primary DI
- 05415067050090
- Version / Model
- CDHFA500B
- Catalog Number
- CDHFA500B
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-11
- Public Version
- 1
- Public Version Date
- 2025-02-19
- Public Version Status
- New
- Public Device Record Key
- f3e83b02-0271-49f1-b795-7078224f8ea9
Device Description
HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
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 |
|---|---|---|---|---|
| LWO | Pulse-generator, single chamber, sensor driven, implantable | Unknown | 3 | |
| LWP | Implantable pulse generator, pacemaker (non-CRT) | Unknown | 3 | |
| DXY | implantable pacemaker Pulse-generator | Cardiovascular | 870.3610 | 3 |
| PNJ | Leadless pacemaker | Cardiovascular | 870.3610 | 3 |
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) | Unknown | 3 | |
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | Unknown | 3 | |
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes | Unknown | 3 | |
| LWS | Implantable cardioverter defibrillator (non-CRT) | 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 | 05415067050090 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit