Catalog Number

-

Brand Name

NatureSpirit

Version/Model Number

CMS-50d

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

54c934f5-cff0-4509-8501-b747c7507ef3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 09, 2017

Package DI Number

10897037001073

Quantity per Package

24

Contains DI Package

00897037001076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton