Catalog Number

-

Brand Name

Tempus LS-Manual

Version/Model Number

01-3022

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

K200849

Product Code

LDD

Product Code Name

Dc-Defibrillator, Low-Energy, (Including Paddles)

Public Device Record Key

286c7c19-5270-49b7-91e9-f9eac64d3123

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-