FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Model 1620 AC Recharger
DI: 00857334004200
·
Model: 1620
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Model 1620 AC Recharger
- Primary DI
- 00857334004200
- Version / Model
- 1620
- Catalog Number
- 1620
- 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
- 7
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- f0da9ec9-56fb-49a8-bd08-8b966830699c
- Distribution End Date
- 2020-10-01
Device Description
The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger.
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 |
|---|---|---|---|---|
| 17115 | Noninvasive device battery charger | An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857334004200 | GS1 |
Customer Contacts
- Phone
- +1(651)789-2681
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130019 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9.5 | Inch |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 150 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius