Catalog Number

-

Brand Name

IDEAL LIFE SPO2 Manager™

Version/Model Number

POM 0001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2016

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

87dee5fd-268b-42a8-9e3a-1f2afa7d4bb5

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

10804084000072

Quantity per Package

200

Contains DI Package

10804084000065

Package Discontinue Date

November 30, 2016

Package Status

Not in Commercial Distribution

Package Type

-