DEVICE: N'VISION™ (00613994997845)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
N'VISION™
8840
In Commercial Distribution

MEDTRONIC, INC.
00613994997845
GS1

1
796986144 *Terms of Use
PRGMR 8840 N'VISION PHYSICN W LOANER INS
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MHY STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
LNQ intestinal Stimulator
MRU implanted subcortical electrical Stimulator (motor disorders)
LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MFR Stimulator, brain, implanted, for behavior modification
EZW Stimulator, electrical, implantable, for incontinence
OLM Deep brain stimulator for obsessive compulsive disorder (OCD)
NHL STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
QON Implanted electrical device intended for treatment of fecal incontinence
PJS Stimulator, electrical, implanted, for essential tremor
QRB Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P080025 018
P840001 195
P860004 157
P960009 125
P970004 125
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 65 Degrees Celsius
Handling Environment Temperature: between -40 and 149 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
4c127bad-576b-4ba3-8976-2f26be215335
July 31, 2023
4
September 23, 2014
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
CLOSE