FDA.reportPublic FDA data

Tempus LS-Manual

Primary DI
05060472441973
Brand
Tempus LS-Manual
Company
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
Model
01-3023
Device description
Tempus LS-Manual CPR Feedback Sensor
Published
2020-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200849000Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company2020-07-24LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060472441973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060472441973050604724419735060472441973

GMDN Terms#

Term, Definition table
TermDefinition
Physiologic-monitoring defibrillation systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896707940
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060472442901Tempus Pro00-1004-R8674202022-09-08
05060472440112Tempus Pro01-20172016-09-16
05060472440785Tempus Pro01-22432017-06-30
05060472441027Tempus Pro00-1024-R2018-01-16
05060472441058Tempus Pro00-1026-R2018-01-16
05060472441218Tempus Pro01-21792017-11-09
05060472441423Tempus LS-Manual01-30122020-11-02
05060472441539Tempus LS-Manual01-30252020-11-02
05060472442949Tempus IC200-2001-R8673742022-09-08
05060472441966Tempus LS-Manual01-30222020-08-06
05060472440020Tempus Pro00-1004-R2016-09-16
05060472440389Tempus Pro01-20532016-09-16
05060472440433Tempus IC201-25062016-10-04
05060472440440Tempus IC201-20992016-09-16
05060472440488Tempus IC200-2001-R2016-09-16
05060472440013Tempus Pro00-1007-R2016-09-16
05060472440129Tempus Pro01-21012016-09-16
05060472440303Tempus Pro01-20492016-09-16
05060472440310Tempus Pro01-10122016-09-16
05060472440457Tempus IC201-20202016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817392026248UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026255UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026217UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026224UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026231UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392025647UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025654UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025593UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025609UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
07613365002737Tempus LS-MANUALSchiller AGLDD2020-08-11
08054242441765NAFIAB SPALDD2020-04-12
08054242441772NAFIAB SPALDD2020-04-12
08054242441789NAFIAB SPALDD2020-04-12
08054242441796NAFIAB SPALDD2020-04-12
08054242441802NAFIAB SPALDD2020-04-12
08054242441819NAFIAB SPALDD2020-04-12
08054242441826NAFIAB SPALDD2020-04-12
08054242441833NAFIAB SPALDD2020-04-12
08054242441840NAFIAB SPALDD2020-04-12
08054242441857NAFIAB SPALDD2020-04-12
08054242441871NAFIAB SPALDD2020-04-12
08054242441895NAFIAB SPALDD2020-04-12
08054242444933NAFIAB SPALDD2020-04-12
08054242446425NAFIAB SPALDD2020-04-12
08054242446432NAFIAB SPALDD2020-04-12