FDA.reportPublic FDA data

CARESCAPE

Primary DI
00840682109826
Brand
CARESCAPE
Company
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Model
Central Station v1
Device description
ASSY CSCS V1 MP100D DESKTOP
Published
2016-06-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSEANALYZER, GAS, HELIUM, GASEOUS-PHASE
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.)
CCIANALYZER, GAS, NITROGEN, GASEOUS-PHASE
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE
DOARADIOIMMUNOASSAY, DIGOXIN (125-I), GOAT ANTIBODY, ANION EXCHANGE, RESIN SEP.
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR
DSBPLETHYSMOGRAPH, IMPEDANCE
DSKCOMPUTER, BLOOD-PRESSURE
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
GWQFull-montage Standard Electroencephalograph
JEGANALYZER, GAS, ARGON, GASEOUS-PHASE
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
BSEAnalyzer, Gas, Helium, Gaseous-PhaseAnesthesiology2
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
CCIAnalyzer, Gas, Nitrogen, Gaseous-PhaseAnesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.Clinical Toxicology2
DPTProbe, Blood-Flow, ExtravascularCardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
GWQFull-Montage Standard ElectroencephalographNeurology2
JEGAnalyzer, Gas, Argon, Gaseous-PhaseAnesthesiology2
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
K133882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133882000CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)Ge Medical Systems Information Technologies, Inc.2014-04-30DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682109826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682109826008406821098268406821098260840682109826

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 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
00195278490742VSP4.058772592026-11-03
00840682117425NA2017842-0012016-07-08
00840682117531NA2023808-0022016-07-08
00840682117661NA2024565-0022016-07-08
00840682117678NA2024696-0012016-07-08
00840682118156N/A2017099-0032016-07-22
00840682118095N/A2017099-0012016-07-22
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

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06927709405452AmetmedShenzhen Jamr Technology Co., Ltd.DXN2026-11-03
10860015046014XChangePneuma Therapeutics, Inc.CCK2026-11-02
00841709121746MidmarkMIDMARK CORPORATIONDXN2026-10-30
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