Catalog Number

-

Brand Name

NatureSpirit

Version/Model Number

CP-500E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 21, 2050

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

K172141,K172141

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

2b66e2e8-71fb-4e5c-b20e-bf523676df5f

Public Version Date

April 29, 2020

Public Version Number

1

DI Record Publish Date

April 21, 2020

Package DI Number

10897037001110

Quantity per Package

200

Contains DI Package

00897037001113

Package Discontinue Date

April 21, 2050

Package Status

In Commercial Distribution

Package Type

Carton