Catalog Number

015-0667-00

Brand Name

Trulink

Version/Model Number

SUPPLY

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 2017

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103142,K103142

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

9ceda6c0-aa9c-428c-92f8-f17d1d0b9a6d

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

December 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-