FDA UDI
In Commercial Distribution
🇺🇸 United States
N'VISION®
DI: 00613994452191
·
Model: 8840
·
MEDTRONIC, INC.
Product Codes
12
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N'VISION®
- Primary DI
- 00613994452191
- Version / Model
- 8840
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 95ec3e6b-5a52-42e7-91d4-0704213bab06
Device Description
PRGMR 8840 NVISION PHYSICIAN LOANR INSRT
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MFR | Stimulator, brain, implanted, for behavior modification | Unknown | f | |
| MHY | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | Unknown | 3 | |
| OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) | Unknown | f | |
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | Unknown | 3 | |
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | Unknown | 3 | |
| NHL | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | Unknown | 3 | |
| LNQ | intestinal Stimulator | Unknown | f | |
| EZW | Stimulator, electrical, implantable, for incontinence | Gastroenterology, Urology | 876.5270 | 3 |
| MRU | implanted subcortical electrical Stimulator (motor disorders) | Unknown | f | |
| QON | Implanted electrical device intended for treatment of fecal incontinence | Gastroenterology, Urology | 876.5270 | 3 |
| QRB | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy | Unknown | 3 | |
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61393 | Multiple active implantable device programmer | An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994452191 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H020007 | 013 |
| H050003 | 000 |
| P960009 | 027 |