DEVICE: N'VISION™ (00763000875862)
Device Identifier (DI) Information
N'VISION™
8840-RFB
In Commercial Distribution
MEDTRONIC, INC.
8840-RFB
In Commercial Distribution
MEDTRONIC, INC.
PROGRAMMER 8840 CLINICIAN REFURB US
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LGW | Stimulator, spinal-cord, totally implanted for pain relief |
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms |
| OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor |
| PJS | Stimulator, electrical, implanted, for essential tremor |
| QON | Implanted electrical device intended for treatment of fecal incontinence |
| EZW | Stimulator, electrical, implantable, for incontinence |
| LKK | Pump, infusion, implanted, programmable |
| LNQ | intestinal Stimulator |
| MRU | implanted subcortical electrical Stimulator (motor disorders) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| H020007 | 000 |
| H050003 | 000 |
| P080025 | 000 |
| P840001 | 061 |
| P860004 | 052 |
| P960009 | 025 |
| P970004 | 023 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -40 and 65 Degrees Celsius |
| Storage Environment Temperature: between -40 and 149 Degrees Fahrenheit |
| Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6e515998-2553-47cf-bf0f-2914c24e7d7f
March 14, 2024
2
November 16, 2023
March 14, 2024
2
November 16, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com