Catalog Number

-

Brand Name

TC 550 Fixation Ring for tcpO2/CO2

Version/Model Number

TC 550

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

K990960,K990960

Product Code

KLK

Product Code Name

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Public Device Record Key

909bcb9c-5a04-45f8-b93e-2615681cbcba

Public Version Date

May 21, 2021

Public Version Number

4

DI Record Publish Date

February 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-