Catalog Number

-

Brand Name

NatureSpirit

Version/Model Number

CP-50BLE

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

457606a2-070d-4ea1-9573-0e499722a911

Public Version Date

April 29, 2020

Public Version Number

1

DI Record Publish Date

April 21, 2020

Package DI Number

10897037001684

Quantity per Package

200

Contains DI Package

00897037001687

Package Discontinue Date

April 21, 2050

Package Status

In Commercial Distribution

Package Type

Carton