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DEVICE DETAILS

NAME OF DEVICEINVOS 5100C CEREBRAL/SOMATIC OXIMETER & ACCESSORIES
ESTABLISHMENT NAMEMEDTRONIC MALAYSIA SDN BHD
REGISTRATION NOGC39155628318
BRAND NAMEINVOS
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONTHE INVOS CEREBRAL/SOMATIC OXIMETER MODEL 5100C IS A PATIENT MONITOR THAT CONTINUOUSLY AND NONINVASIVELY MEASURES THE BLOOD OXYGEN SATURATION IN CEREBRAL OR SOMATIC REGION OF THE BODY, FOR ADULT OR PEDIATRIC APPLICATION.
DEVICE INTENDED PURPOSETHE NONINVASIVE INVOS 5100C IS INTENDED FOR USE AS AN ADJUNCT MONITOR OF REGIONAL HEMOGLOBIN OXYGEN SATURATION OF BLOOD IN THE BRAIN OR IN OTHER TISSUE BENEATH THE SENSOR. IT IS INTENDED FOR USE IN INDIVIDUALS GREATER THAN 2.5 KG AT RISK FOR REDUCED-FLOW OR NO-FLOW ISCHEMIC STATES. IT IS ALSO INTENDED FOR USE AS AN ADJUNCT TREND MONITOR OF REGIONAL HEMOGLOBIN OXYGEN SATURATION OF BLOOD IN THE BRAIN OR IN OTHER TISSUE BENEATH THE SENSOR IN ANY INDIVIDUAL.
VALIDITY DATE OF REGISTRATION11/01/2018 - 10/01/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1INVOS Regional Saturation Patient Monitor5100C-EU
2INVOS Regional Saturation Patient Interface Module5100C-PA
3INVOS Regional Saturation Patient Interface Module5100C-PB
4INVOS Regional Saturation Patient Interface Module5100C-PA-INT
5INVOS Regional Saturation Patient Interface Module5100C-PB-INT
6INVOS Regional Saturation Patinet Interface Cable RSC-1
7INVOS Regional Saturation Patinet Interface Cable RSC-2
8INVOS Regional Saturation Patinet Interface Cable RSC-3
9INVOS Regional Saturation Patinet Interface Cable RSC-4
10INVOS Adult Regional Saturation SensorSAFB
11INVOS Pediatric Regional Saturation SensorSPFB
12INVOS Pediatric Regional Saturation SensorSPFBX10
13INVOS Pediatric Regional Saturation SensorSPFBX20
14INVOS Adult Regional Saturation SensorSAFB-SM
15INVOS Adult Regional Saturation SensorSAFB-SMX10
16INVOS Adult Regional Saturation SensorSAFB-SMX20
17INVOS Adult Regional Saturation SensorSAFB-SM/INTL
18INVOS Adult Regional Saturation SensorSAFB-SM/INTL20
19INVOS Pediatric Regional Saturation SensorSPFB/INTL
20INVOS Pediatric Regional Saturation SensorSPFB/INTL20
21INVOS Infant Regional Saturation Sensor CerebralCNN
22INVOS Infant Regional Saturation Sensor SomaticSNN
23INVOS Infant Regional Saturation Sensor Cerebral/SomaticCNN/SNN
245100C MULTILINGUAL CD SW 40.10.10314039
25INVOS Adapter Plate5100C-GCX
26INVOS Roll Stand5100C-RS
27INVOS Swivel Arm5100C-SA
28INVOS USB Flash Drive5100C-USB