FDA.reportPublic FDA data

3-Lead Leadset,Telemetry,AHA,Snap

Primary DI
06944904049595
Brand
3-Lead Leadset,Telemetry,AHA,Snap
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-004867-00
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSXSYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904049595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904049595069449040495956944904049595

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, reusableA temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
654671304
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
06936415973643VS 9 Vital Signs MonitorVS 92025-01-24
06936415973650VS 8 Vital Signs MonitorVS 82025-01-24
06936415973667VS 8A Vital Signs MonitorVS 8A2025-01-24
06936415972417BeneVision Central Monitoring SystemBeneVision2024-09-24
06944904055152BeneVision Central Monitoring SystemBeneVision115-034413-002015-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MSX2026-03-18
B153301030AirStrip ONE Client WebAirstrip Technologies, Inc.MSX2026-03-18
B153500010AirStrip Alarm ManagementAirstrip Technologies, Inc.MSX2026-03-18
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00843997019019Patient SafetyNet LiteMASIMO CORPORATIONMSX2026-02-23
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyMSX2025-12-10
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCMSX2025-06-30
00853858006584EmpaticaEMPATICA SRLMSX2025-06-26
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
G2871002HUMAMedoPad Inc.MSX2025-04-28
00850064210262Sibel Spacelabs Trek TabletSibel Health Inc.MSX2025-04-02
00850064210163Central Hub CMSSibel Health Inc.MSX2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.MSX2025-03-27
00850064210132ANNE View Patient MonitorSibel Health Inc.MSX2025-03-26
00884838126381eCareManagerPhilips Medical Systems Nederland B.V.MSX2025-03-17
00860011811961MessengerSPOK INC.MSX2025-02-19
04048675673408Gateway Software Server VF9.0.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675762256Gateway Software Server VF9.1.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675777762Gateway Software Server VF9.1.2DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098007061Infinity Gateway USB DongleDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098099264S/W SUB VF9.0 GatewayDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19