FDA.reportPublic FDA data

BIS module (w accessory kit)

Primary DI
06944904096728
Brand
BIS module (w accessory kit)
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-046969-00
Published
2020-05-08
Public version status
New
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
K190011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190011000Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-07-10MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904096728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904096728069449040967286944904096728

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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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Primary DI, Brand, Company table
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00690103219609VitaWaveEdwards Lifesciences LLCOLW2025-09-10
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCOLW2024-05-13
10884521808270BISCovidien LPOLW2024-04-28
10884521808300BISCovidien LPOLW2024-04-28
10884521808317BISCovidien LPOLW2024-04-28
10884521533103BISCovidien LPOLW2024-03-01
00690103218848HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
10843997012802RD SedlineMASIMO CORPORATIONOLW2023-08-22
00843997013475SedLineMASIMO CORPORATIONOLW2023-08-22
00843997013895SedLineMASIMO CORPORATIONOLW2023-08-22
00843997012805RD SedlineMASIMO CORPORATIONOLW2023-08-22
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
00195278524089NAGE Healthcare Finland OyOLW2023-04-19
10884521713055BISCovidien LPOLW2023-01-21
B746NS90101NeuroSENSENeurowave Systems Inc.OLW2022-10-21
10884521812376BISCovidien LPOLW2022-09-24
00840682146111CARESCAPE B650GE Healthcare Finland OyOLW2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyOLW2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyOLW2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12