Tempus LS-MANUAL

Basic Information

• Brand Name: Tempus LS-MANUAL
• Primary DI: 07613365002737
• Version / Model: 3.940589
• Catalog Number: 00-3020
• Company Name: Schiller AG
• Labeler DUNS: 480868538
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-11
• Public Version: 2
• Public Version Date: 2020-09-11
• Public Version Status: Update
• Public Device Record Key: 4e340db2-db5a-4a47-ba9d-36ce8f291242

Device Description

The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	870.5550	2
DPS	Electrocardiograph	Cardiovascular	870.2340	2
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	870.5210	2
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	870.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17882	Physiologic-monitoring defibrillation system	An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613365002737	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K200849	000