Catalog Number

NXBNOXKIT-2-22

Brand Name

NOxBOXi

Version/Model Number

NOXKIT-2-22

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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

K171696,K171696,K171696

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Public Device Record Key

20677256-ef16-4aa4-af33-7b5c345a2898

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Package DI Number

25060541640034

Quantity per Package

4

Contains DI Package

15060541640037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON