AccessGUDID - DEVICE: CARESCAPE ONE (00840682125901)

GUDID

Device Identifier (DI) Information

Brand Name: CARESCAPE ONE
Version or Model: MBZ101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Primary DI Number: 00840682125901
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 006580799 *Terms of Use

Device Description: CARESCAPE ONE MBZ101 ATO MODEL

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36553	Patient monitoring system module, multifunction	A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200494	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 108 KiloPascal
Storage Environment Temperature: between -30 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03923789-677e-4547-8fb2-1a3ea8fab143
Public Version Date: May 09, 2025
Public Version Number: 3
DI Record Publish Date: April 07, 2020