FDA.reportPublic FDA data

ICG module (w accessory kit)

Primary DI
06944904096780
Brand
ICG module (w accessory kit)
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-047305-00
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
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

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
06944904096780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904096780069449040967806944904096780

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

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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
04260451441180Osypka MedicalOsypka Medical GmbHDSB2026-04-24
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDSB2026-03-16
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCDSB2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCDSB2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCDSB2025-09-10
B719G73C0Valhalla Scientific, IncValhalla ScientificDSB2025-07-28
00690103219616ForeSight IQEdwards Lifesciences LLCDSB2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDSB2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDSB2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DSB2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DSB2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DSB2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DSB2025-03-13
00690103218879HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
B719G62J0Valhalla Scientific, IncValhalla ScientificDSB2024-06-17
B719G63C0Valhalla Scientific, IncValhalla ScientificDSB2024-04-12
B719BE3B0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G61S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62Q0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15