Catalog Number

568011

Brand Name

Nox A1 Carry Case

Version/Model Number

NOX-A1_CC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

b7fc9385-1736-4af9-8deb-4056e5de7b99

Public Version Date

October 26, 2020

Public Version Number

2

DI Record Publish Date

April 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-