FDA.reportPublic FDA data

Respiratory Mech mod,w/accssry

Primary DI
06944904096766
Brand
Respiratory Mech mod,w/accssry
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-047304-00
Published
2020-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXPTransducer, Gas Flow

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXPTransducer, Gas FlowAnesthesiology1

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
06944904096766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904096766069449040967666944904096766

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838105584Flow SensorRespironics Novametrix, LLCBXP2023-11-15
00884838105607Flow SensorRespironics Novametrix, LLCBXP2023-11-15
30884838105585RespironicsRespironics Novametrix, LLCBXP2023-11-15
30884838105608RespironicsRespironics Novametrix, LLCBXP2023-11-15
07640142190479Spiro-SP TrueFlow SensorNDD Medizintechnik AGBXP2023-06-23
20884521210933Puritan BennettCovidien LPBXP2023-02-03
10884521210936Puritan BennettCovidien LPBXP2023-02-03
04048675000099Neonatal flow sensor ISO15Drägerwerk AG & Co. KGaABXP2022-04-08
04048675005612SpiroLifeDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448853Neonatal flow sensor insertDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448860Spirolog Flow SensorDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448938Infinity ID Flow SensorDrägerwerk AG & Co. KGaABXP2022-04-08
20884521139852Puritan BennettCovidien LPBXP2021-04-15
10884521139855Puritan BennettCovidien LPBXP2021-04-15
00884838014114Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014121Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014138Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014145Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014152Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014350Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014367Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014374Flow SensorRespironics Novametrix, LLCBXP2020-09-14
06420099000554M9256, SpiroSafe Disposable Flow TransducerMedikro OyBXP2018-07-13
06420099000561M9256, SpiroSafe Disposable Flow TransducerMedikro OyBXP2018-07-13
04036616001809Flow sensorHoneywell Healthcare Solutions GmbHBXP2016-09-22
04049098007740Respiratory Mechanics Flow Sensor – Adult/PediatricDRAEGER MEDICAL SYSTEMS, INC.BXP2015-11-02