FDA.reportPublic FDA data

Kit, DPM4, DPM5, Nellcor SpO2

Primary DI
06944904086453
Brand
Kit, DPM4, DPM5, Nellcor SpO2
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
0020-00-0190-09
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904086453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904086453069449040864536944904086453

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags#

DUNS number
654671304
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06903053010641M-30CFL LYSEM-30CFL105-026307-002026-01-22
06936415908805M-30CFL LYSEM-30CFL105-006209-002026-01-22
06936415908812M-30CFL LYSEM-30CFL105-006210-002026-01-22
06936415994457PROBE CLEANSERPROBE CLEANSER105-009432-002026-01-22
06944904030210PROBE CLEANSERPROBE CLEANSER105-002225-002026-01-22
06944904093116M-5LEO(I) LyseM-5LEO(I)105-011724-002026-01-22
06944904093123M-5LEO(I) LyseM-5LEO(I)105-011725-002026-01-22
06944904093130M-5LEO(II) LyseM-5LEO(II)105-011729-002026-01-22
06944904093147M-5LEO(II) LyseM-5LEO(II)105-011730-002026-01-22
06944904093154M-53LH LYSEM-53LH105-011734-002026-01-22
06944904093161M-53LH LYSEM-53LH105-011735-002026-01-22
06944904096674SV600 VentilatorSV6002025-01-17
06944904096681SV800 VentilatorSV8002025-01-17
06903053001755Diagnostic Ultrasound SystemTE5 MAX2026-01-10
06903053001762Diagnostic Ultrasound SystemTE7 Max2026-01-10
06903053001779Diagnostic Ultrasound SystemTE92026-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838119079Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119086Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119093Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119109Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119116Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119123Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119147Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119154Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119161Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119178Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838128880Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
04538612228483FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-03-06
00884838086678Masimo Sedline ModulePhilips Medizin Systeme Böblingen GmbHMHX2026-01-15
00199874152509MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
00199874432199MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
04538612916236FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916243FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916250FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916267FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612061905FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916281FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916304FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916403FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
00884838127074Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838107809Patient Monitor 6500Philips Medizin Systeme Böblingen GmbHMHX2025-11-11
06944413838420Patient MonitorEdan Instruments, Inc.MHX2025-09-05