FDA UDI In Commercial Distribution 🇺🇸 United States

CARESCAPE

DI: 00840682103091 · Model: V100 · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CARESCAPE
Primary DI
00840682103091
Version / Model
V100
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
2016-05-20
Public Version
5
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
2e8851f9-b77e-400c-842b-64da95873bea

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
MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
MWI MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
DQA Oximeter
FLL Thermometer, electronic, clinical

GMDN Terms

Code Name
36872 Multiple vital physiological parameter monitoring system, clinical

Identifiers

Type ID
Primary 00840682103091