N'VISION®

GUDID 00643169640863

SFTWR 8870AAU01 N'VISION AAU/01

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00643169640863
NIH Device Record Keya971149c-8fe6-46b6-8beb-cb532b5ed528
Commercial Distribution StatusIn Commercial Distribution
Brand NameN'VISION®
Version Model Number8870AAU01
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169640863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2016-10-08