FDA.reportPublic FDA data

BIS Module(Package/no accessory)

Primary DI
06944904085883
Brand
BIS Module(Package/no accessory)
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-013217-00
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
06944904085883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904085883069449040858836944904085883

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electroencephalographicA small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags#

DUNS number
654671304
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936415904661MR Na/K Check Solution105-011386-002026-01-23
06936415904678MR Detergent Solution105-011383-002026-01-23
06936415904685MR Buffer Solution105-011382-002026-01-23
06944904084459Chemistry AnalyzerCLC720i2026-01-23
06903053010641M-30CFL LYSEM-30CFL105-026307-002026-01-22
06936415908805M-30CFL LYSEM-30CFL105-006209-002026-01-22
06936415908812M-30CFL LYSEM-30CFL105-006210-002026-01-22
06936415994457PROBE CLEANSERPROBE CLEANSER105-009432-002026-01-22
06944904030210PROBE CLEANSERPROBE CLEANSER105-002225-002026-01-22
06944904093116M-5LEO(I) LyseM-5LEO(I)105-011724-002026-01-22
06944904093123M-5LEO(I) LyseM-5LEO(I)105-011725-002026-01-22
06944904093130M-5LEO(II) LyseM-5LEO(II)105-011729-002026-01-22
06944904093147M-5LEO(II) LyseM-5LEO(II)105-011730-002026-01-22
06944904093154M-53LH LYSEM-53LH105-011734-002026-01-22
06944904093161M-53LH LYSEM-53LH105-011735-002026-01-22
06936415973643VS 9 Vital Signs MonitorVS 92025-01-24
06936415973650VS 8 Vital Signs MonitorVS 82025-01-24
06936415973667VS 8A Vital Signs MonitorVS 8A2025-01-24
06936415972417BeneVision Central Monitoring SystemBeneVision2024-09-24
06944904055152BeneVision Central Monitoring SystemBeneVision115-034413-002015-10-20

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Primary DI, Brand, Company table
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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
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00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMHX2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyMHX2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyMHX2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyMHX2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyMHX2022-07-01
00840682146111CARESCAPE B650GE Healthcare Finland OyMHX2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyMHX2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyMHX2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.MHX2022-04-12
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