Catalog Number

536210

Brand Name

Noxturnal APP

Version/Model Number

NOX-NOXTURNAL_APP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 2021

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192469

Product Code

KZM

Product Code Name

Device, Muscle Monitoring

Public Device Record Key

0e2dd240-5db7-4b2c-a4d8-71c9b7e98073

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

February 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-