FDA.reportPublic FDA data

"19""display(adapter/2.3M"

Primary DI
06936415902650
Brand
"19""display(adapter/2.3M"
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-044997-00
Published
2020-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2

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
06936415902650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415902650069364159026506936415902650

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCBR2026-04-15
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBR2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBR2024-12-19
06944413815889Patient MonitorEdan Instruments, Inc.CBR2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.CBR2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.CBR2024-06-17
10841522127373TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-06-07
00841522127376TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-06-07
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-05-13
10841522127366TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-04-22
00841522127369TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-04-22
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCBR2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCBR2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCBR2023-04-19
00195278524089NAGE Healthcare Finland OyCBR2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCBR2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCBR2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCBR2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682104135NAGE Healthcare Finland OyCBR2022-03-07
00840682104302NAGE Healthcare Finland OyCBR2022-03-07
00840682141291B1X5 Software UpgradeGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBR2020-11-18
00840682138574NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBR2020-11-16
00840682138581NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBR2020-11-16
06936415902360SMR integrated mount accessory KitShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBR2020-05-06
06936415902681"19""display(adapter/10M/VP1)"Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CBR2020-05-06