Catalog Number

-

Brand Name

Tempus Pro

Version/Model Number

01-2186

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

-

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

-

Product Code

MHX

Product Code Name

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Public Device Record Key

07cdfc5f-93a2-4b5a-99fe-e1b237f4019b

Public Version Date

September 23, 2022

Public Version Number

6

DI Record Publish Date

January 16, 2018

Package DI Number

15060472441147

Quantity per Package

10

Contains DI Package

05060472441140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box