Catalog Number

21-00809

Brand Name

TruLink

Version/Model Number

015-0667-00

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

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

K030952

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

be7ae8bf-fa95-47f0-b3ff-99b933054501

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

February 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-