FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARESCAPE Central Station
DI: 00840682109604
·
Model: V2 Standard MAS 700
·
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CARESCAPE Central Station
- Primary DI
- 00840682109604
- Version / Model
- V2 Standard MAS 700
- Company Name
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Labeler DUNS
- 784985108
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-11
- Public Version
- 6
- Public Version Date
- 2025-04-22
- Public Version Status
- Update
- Public Device Record Key
- 3561396b-922b-4899-8ad7-2ca1be1d732a
- Distribution End Date
- 2022-12-31
Device Description
CARESCAPE CENTRAL STATION V2 MAS 700 ATO MODEL
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 |
|---|---|---|---|---|
| DSI | DETECTOR AND ALARM, ARRHYTHMIA | Cardiovascular | 870.1025 | 2 |
| DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | Cardiovascular | 870.2450 | 2 |
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | Cardiovascular | 870.1425 | 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 | 00840682109604 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162012 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1075 KiloPascal