FDA.reportPublic FDA data

NA

Primary DI
00840682103862
Brand
NA
Company
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Model
B40 Patient Monitor
Device description
B40V3 ATO GENERIC MODEL
Published
2016-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZQMonitor, breathing frequency
CBQANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
CBRANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
CBSANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE
DQAOximeter
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DSBPLETHYSMOGRAPH, IMPEDANCE
DSKCOMPUTER, BLOOD-PRESSURE
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
FLLThermometer, electronic, clinical
GWQFull-montage Standard Electroencephalograph
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
NHOAnalyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
NHPAnalyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
NHQAnalyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
GWQFull-Montage Standard ElectroencephalographNeurology2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130584000MONITOR B40Ge Medical Systems China Co., Ltd.2013-06-26MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682103862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682103862008406821038628406821038620840682103862

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-5120xx@xx.xx

Regulatory Flags#

DUNS number
784985108
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682119269NA3300782016-07-15
00840682119276NA3300882016-06-30
00840682104852NA2017098-0012016-07-22
00840682108928ApexProCH Transmitter2016-06-10
00840682109383CARESCAPET14 Transmitter2016-06-10
00840682116602NA2017008-0032016-07-15
00840682105491SOFT-CUFSFT-F1-2E2016-06-30
00840682106818SOFT-CUF21262016-06-30
00840682107150SOFT-CUF2362-INT2362-INT2016-06-30
00840682108805CLASSIC-CUF23592016-06-30
00840682108874CLASSIC-CUF23582016-06-30
00840682109215CLASSIC-CUF21382016-06-30
00840682109291CLASSIC-CUF21332016-06-30
00840682109307CLASSIC-CUF21192016-06-30
00840682109437CLASSIC-CUF230723072016-06-30
00840682109635CLASSIC-CUF230223022016-06-30
00840682109710CLASSIC-CUF230523052016-06-30
00840682110778SENSA-CUF24702016-06-30
00840682110792SENSA-CUF24622016-06-30
00840682110822SENSA-CUF24642016-06-30

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