CARESCAPE

Basic Information

• Brand Name: CARESCAPE
• Primary DI: 00840682109826
• Version / Model: Central Station v1
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Labeler DUNS: 784985108
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-24
• Public Version: 4
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 2b2165e2-b403-46f1-8fce-b600178bd621

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBQ	ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)	Anesthesiology	868.1500	2
DXJ	DISPLAY, CATHODE-RAY TUBE, MEDICAL	Cardiovascular	870.2450	2
DOA	RADIOIMMUNOASSAY, DIGOXIN (125-I), GOAT ANTIBODY, ANION EXCHANGE, RESIN SEP.	Clinical Toxicology	862.3320	2
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1700	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CCI	ANALYZER, GAS, NITROGEN, GASEOUS-PHASE	Anesthesiology	868.1690	2
CBS	ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1620	2
DSB	PLETHYSMOGRAPH, IMPEDANCE	Cardiovascular	870.2770	2
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
NHO	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2
BSE	ANALYZER, GAS, HELIUM, GASEOUS-PHASE	Anesthesiology	868.1640	2
JEG	ANALYZER, GAS, ARGON, GASEOUS-PHASE	Anesthesiology	868.1075	2
DPT	PROBE, BLOOD-FLOW, EXTRAVASCULAR	Cardiovascular	870.2120	2
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682109826	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133882	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity