FDA.reportPublic FDA data

Tempus IC2

Primary DI
05060472442949
Brand
Tempus IC2
Company
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
Model
00-2001-R
Catalog number
867374
Device description
Tempus IC2 Patient Monitor
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
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152124000Tempus IC2Remote Diagnostics Technologies, Ltd.2015-10-28MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060472440488PreviousGS10
05060472442949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060472440488050604724404885060472440488
05060472442949050604724429495060472442949

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
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
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
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.MWI2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08