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
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

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