FDA.reportPublic FDA data

IBP Module

Primary DI
06936415905576
Brand
IBP Module
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-047286-00
Published
2020-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

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
06936415905576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415905576069364159055766936415905576

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

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
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
06903053124706Diagnostic Ultrasound SystemMU7T2026-06-03
06903053124720Diagnostic Ultrasound SystemMU7P2026-06-03
06903053124775Diagnostic Ultrasound SystemMU9 Exp2026-06-03
06903053124829Diagnostic Ultrasound SystemMU7 Exp2026-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213208Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213369Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213666Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213741Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213888Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214007Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214083Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214120Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214168Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214243Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214342Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214380Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214441Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214472Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214632Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214663Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24