Catalog Number

-

Brand Name

IDEAL LIFE SPO2 Manager™

Version/Model Number

POM 0001

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

a80d453b-c25c-421d-a658-16357acf7fa0

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

December 02, 2016

Package DI Number

10804084000102

Quantity per Package

200

Contains DI Package

00804084000105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-