Catalog Number

CMMST5S

Brand Name

Starling Monitor with SpO2 Module

Version/Model Number

CMMST5S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103166

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

3493517e-eb66-439c-997e-c5a856510916

Public Version Date

August 12, 2022

Public Version Number

7

DI Record Publish Date

April 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-