FDA.reportPublic FDA data

Tempus Pro

Primary DI
05060472442901
Brand
Tempus Pro
Company
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
Model
00-1004-R
Catalog number
867420
Device description
Tempus Pro Rainbow - with Capnometry & without BT Dock
Published
2022-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060472440020PreviousGS10
05060472442901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060472440020050604724400205060472440020
05060472442901050604724429015060472442901

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

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
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
05060472440495Tempus IC200-2001-S2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00840682144292CARESCAPEGe Medical Systems Information Technologies, Inc.MHX2025-06-04
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
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00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14