Catalog Number

-

Brand Name

Reusable SpO2 Sensors

Version/Model Number

SS-018-AF10

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181270

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

4a689de8-c221-4845-a4f7-3259f8169be2

Public Version Date

September 06, 2022

Public Version Number

3

DI Record Publish Date

December 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-