Catalog Number

TS-RTW-100

Brand Name

TruSignal SpO2

Version/Model Number

TS-RTW-100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040831

Product Code

DPZ

Product Code Name

Oximeter, ear

Public Device Record Key

2b14508a-d11b-4ca4-ad5d-858efcefb653

Public Version Date

September 13, 2021

Public Version Number

1

DI Record Publish Date

September 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-