DEVICE: NA (00840682104432)

Device Identifier (DI) Information

NA
2040427-001
In Commercial Distribution

GE Healthcare Finland Oy
00840682104432
GS1

1
401966697 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrical-only medical device connection cable, reusable A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
ORT Burst suppression detection software for electroencephalograph
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
OMC Reduced- montage standard electroencephalograph
BZL COMPUTER, OXYGEN-UPTAKE
GWQ Full-montage Standard Electroencephalograph
CCL ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
DSK COMPUTER, BLOOD-PRESSURE
DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
MLD MONITOR, ST SEGMENT WITH ALARM
MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
DPS ELECTROCARDIOGRAPH
CBQ ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
DSI DETECTOR AND ALARM, ARRHYTHMIA
FLL Thermometer, electronic, clinical
CAP MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
BZK Spirometer, monitoring (w/wo alarm)
DXG COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
OLT Non-normalizing quantitative electroencephalograph software
DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DQA Oximeter
GWJ STIMULATOR, AUDITORY, EVOKED RESPONSE
KOI STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
NHO Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
KRB PROBE, THERMODILUTION
NHP Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
NHQ Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
DPZ Oximeter, ear
CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
DSJ ALARM, BLOOD-PRESSURE
BZQ Monitor, breathing frequency
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE
OLW Index-generating electroencephalograph software
CBS ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131414 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5dc8d208-6292-4480-a763-2144a7556c73
July 06, 2018
3
July 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)558-5120
xx@xx.xx
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