- Physicians Office Resource

SFTWR 8870AAU01 N'VISION AAU/01
N'VISION® - 8870AAU01

Device Description

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.

Environmental Conditions

Storage Environment Temperature - Degrees Fahrenheit

135.00
-30.00

Storage Environment Temperature - Degrees Celsius

57.00
-34.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LKK

Device Name: Pump, Infusion, Implanted, Programmable

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: LGW

Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00643169640863

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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