FDA.reportPublic FDA data

EEG Module w/ Cable

Primary DI
06936415905569
Brand
EEG Module w/ Cable
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-053713-00
Published
2020-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLWIndex-Generating Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLWIndex-Generating Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182075000BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-12-10MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936415905569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415905569069364159055696936415905569

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.

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
06944904003825CABLE,IBP ADAPTER, 12PIN/6PIN0010-20-427952016-09-23
06944904003856CABLE,XDUCER,IBP,EDWARD,12PIN0010-21-121792016-09-23
06944904003870CABLE,XDUCER,IBP,MEMSCAP,6PIN0010-21-430812016-09-23
06944904003887CABLE,XDUCER,IBP,MEMSCAP,12PIN0010-21-430822016-09-23
06944904003894CABLE,XDUCER,IBP,EDWARD,6PIN0010-21-430942016-09-23
06944904030838ECG adapter cable (12-pin to 6-pin)0010-30-430542016-09-23
06944904030272A5 Anesthesia SystemA52015-10-20
06944904039695A7 Anesthesia SystemA72015-10-20
06903053124348Diagnostic Ultrasound SystemMU9 Pro2026-06-03
06903053124355Diagnostic Ultrasound SystemMU9A2026-06-03
06903053124379Diagnostic Ultrasound SystemMU7 Pro2026-06-03
06903053124430Diagnostic Ultrasound SystemMU9 Super2026-06-03
06903053124461Diagnostic Ultrasound SystemMU72026-06-03
06903053124492Diagnostic Ultrasound SystemMU7 Super2026-06-03
06903053124546Diagnostic Ultrasound SystemMU9S2026-06-03
06903053124560Diagnostic Ultrasound SystemMU9P2026-06-03
06903053124591Diagnostic Ultrasound SystemMU92026-06-03
06903053124607Diagnostic Ultrasound SystemMU7S2026-06-03
06903053124614Diagnostic Ultrasound SystemMU7A2026-06-03
06903053124683Diagnostic Ultrasound SystemMU9T2026-06-03

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00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyOLW2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyOLW2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyOLW2023-04-19
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