FDA UDI
In Commercial Distribution
🇺🇸 United States
Vesta
DI: 00810003380135
·
Model: Vesta Charger System (For OPTIMIZER Lite)
·
Impulse Dynamics (usa) Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vesta
- Primary DI
- 00810003380135
- Version / Model
- Vesta Charger System (For OPTIMIZER Lite)
- Catalog Number
- 10-F302-3-XX
- Company Name
- Impulse Dynamics (usa) Inc.
- Labeler DUNS
- 878519342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-26
- Public Version
- 2
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 8e1bcb57-b5c9-49d9-a010-9e10fc3eacdf
Device Description
Vesta Charger System (For OPTIMIZER Lite) consists of: (1) Vesta Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Manual insert
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QFV | Implantable Pulse Generator | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33658 | Implant battery charger | An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device. Battery-powered device types may include a line-powered charger (e.g., docking station); devices intended to hold/stabilise the device during use (e.g., implant battery charger belt/collar) may be included with this device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810003380135 | GS1 |
Customer Contacts
- Phone
- 845-359-2389
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180036 | 021 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit