FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Model 2402 Maestro Mobile Charger
DI: 00857334004309
·
Model: 2402
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Model 2402 Maestro Mobile Charger
- Primary DI
- 00857334004309
- Version / Model
- 2402
- Catalog Number
- 2402
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 144998551
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-04-17
- Public Version
- 6
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- d575342c-8fe1-4970-9f8d-c2cc6e7233ab
- Distribution End Date
- 2020-10-01
Device Description
The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.
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 Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| PIM | neuromodulator for obesity | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64411 | Implant battery charger/performance analyser | An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ, in addition to measuring elements of the status of the implant (e.g., temperature, battery voltage). It may also display alert messages concerning that status to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857334004309 | GS1 |
Customer Contacts
- Phone
- +1(651)789-2681
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130019 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4.7 | Inch | |
| Height | 1.2 | Inch | |
| Length | 2 | Inch |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 150 KiloPascal