Catalog Number

-

Brand Name

Tempus IC

Version/Model Number

01-1020

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

K113105

Product Code

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Public Device Record Key

4195c230-5d23-495f-b4ba-53ac3058f753

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-