CARESCAPE ONE

Basic Information

• Brand Name: CARESCAPE ONE
• Primary DI: 00195278288639
• Version / Model: MBZ323
• Catalog Number: 2087075-300
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Labeler DUNS: 006580799
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-13
• Public Version: 2
• Public Version Date: 2022-05-25
• Public Version Status: Update
• Public Device Record Key: ffba618d-4b4c-4f9d-8c65-be7f54bf9507

Device Description

CARESCAPE ONE MBZ323 ATO MODEL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
DQK	Computer, diagnostic, programmable	Cardiovascular	870.1425	2
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2
MUD	Oximeter, tissue saturation	Cardiovascular	870.2700	2
DPZ	Oximeter, ear	Cardiovascular	870.2710	2
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
DPS	Electrocardiograph	Cardiovascular	870.2340	2
DXN	System, measurement, blood-pressure, non-invasive	Cardiovascular	870.1130	2
QEM	Cerebral oximeter	Cardiovascular	870.2700	2
DSJ	Alarm, blood-pressure	Cardiovascular	870.1100	2
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2
DQA	Oximeter	Cardiovascular	870.2700	2
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2
MLD	MONITOR, ST SEGMENT WITH ALARM	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36872	Multiple vital physiological parameter monitoring system, clinical	An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278288639	GS1

Premarket Submissions

Submission Number	Supplement Number
K213234	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 108 KiloPascal