FDA.reportPublic FDA data

SureSigns VSi

Primary DI
00884838028364
Brand
SureSigns VSi
Company
Philips Medical Systems Hsg
Model
863275
Catalog number
863275
Device description
SureSigns VSi - NBP
Published
2016-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSJAlarm, Blood-Pressure
DSKCOMPUTER, BLOOD-PRESSURE
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112652000SURESIGNS VS2+ -SURESIGNS VSIPhilips Medical Systems2011-10-11DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838028364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838028364008848380283648848380283640884838028364

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure701 millibar1013 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
790605856
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838015245HeartStartExternal Paddles Water ResistantM3543A2014-09-24
00884838090088MX40 Masimo Leadsets and AdaptersMX40 Adapter 5-Lead + Masimo SpO29898032023812022-05-23
00884838090095MX40 Masimo Leadsets and AdaptersMX40 Adapter Masimo SpO2-only9898032023912022-05-23
00884838090101MX40 Masimo Leadsets and AdaptersECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112020-04-21
00884838090118MX40 Masimo Leadsets and AdaptersECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212020-04-21
00884838091276MX40 Masimo Leadsets and AdaptersMX40 Adapter 6-Lead + Masimo SpO29898032042912020-04-21
00884838013360ECG ElectrodesCBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE9898031718112017-07-13
00884838013377ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI, TELE9898031718212016-10-13
00884838013384ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, TELE9898031718312016-09-27
00884838013391ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI + SPO2, TELE9898031718412016-09-27
00884838013407ECG ElectrodesCBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE9898031718512016-09-27
00884838013414ECG ElectrodesCBL ECG 6 LEAD GRABBER, AAMI, TELE9898031718612017-07-27
20884838013517ECG ElectrodesCBL ECG 5 LEAD GRABBER IEC, SPU, TELE9898031721312020-03-25
20884838013494ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE9898031720312016-10-12
00884838013421ECG ElectrodesCBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE9898031718712016-11-22
00884838013445ECG ElectrodesCBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE9898031719112016-11-29
00884838013452ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC, TELE9898031719312016-10-13
00884838013469ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE9898031719512016-10-13
00884838013476ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC, TELE9898031719612016-11-01
00884838013483ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE9898031719712016-12-07

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