Catalog Number

-

Brand Name

Masimo Compatible Disposable SpO2 Sensor, Neonate

Version/Model Number

10208

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181270,K181270

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

41d3cb2a-c912-41e0-a856-5bdcbe5b2b04

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

December 11, 2019

Package DI Number

B817102081

Quantity per Package

20

Contains DI Package

B817102080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-