FDA.reportPublic FDA data

PROPAQ M

Primary DI
00847946080648
Brand
PROPAQ M
Company
Zoll Medical Corporation
Model
213-1011300-01
Device description
PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, FRSS US MILITARY
Published
2024-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DPSElectrocardiograph
DQAOximeter
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DSKCOMPUTER, BLOOD-PRESSURE
DXNSystem, measurement, blood-pressure, non-invasive
FLLContinuous Measurement Thermometer
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DPSElectrocardiographCardiovascular2
DQAOximeterCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946080648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946080648008479460806488479460806480847946080648

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly 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 set-up by the patient bedside and 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 and is not intended to be worn on the body.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
DM exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847946021986HWD Electrode Set9610-000181-012016-10-20
10847946021327Cuffs9355-16402016-09-16
10847946021334Cuffs9355-16412016-09-16
10847946021341Cuffs9355-16422016-09-16
10847946021358Cuffs9355-16432016-09-16
10847946021365Cuffs9355-16442016-09-16
00847946023058ACCUVENT9500-0006632022-11-01
10847946023130PATIENT CIRCUITS812-0008-202022-06-08
10847946023123PATIENT CIRCUITS812-0007-202015-10-28
10847946023147PATIENT CIRCUITS812-0009-202015-10-28
10847946023154PATIENT CIRCUITS812-0010-202015-10-28
10847946023161PATIENT CIRCUITS812-0011-202015-10-28
10847946023215PATIENT CIRCUITS712-0002-202020-10-22
00847946026929RESQPOD ITD 1012-0242-0002020-06-24
20847946023137PATIENT CIRCUITS812-0008-402015-10-28
20847946023182PATIENT CIRCUITS812-0007-402015-10-28
00847946016746ZOLL CABLE1009-0918-012014-09-24
00847946016760ZOLL CABLE1009-0913-022014-09-23
00847946018337Pro-Padz Radiotransparent8900-0051-402019-03-15
00847946021269Sensor9355-0005902016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27