Catalog Number

-

Brand Name

TruSignal SpO2

Version/Model Number

TS-AAW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K132696,K093881,K040831,K040831,K093881,K132696,K093881,K132696,K040831

Product Code

DPZ

Product Code Name

Oximeter, ear

Public Device Record Key

10eef5bd-391c-4eab-99bc-a872dbb2b14c

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

June 27, 2016

Package DI Number

00840682116695

Quantity per Package

10

Contains DI Package

00840682103299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-