FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Surveyor Central
DI: 00817655022147
·
Model: SCNODE-DAA-BXXEX
·
MORTARA INSTRUMENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surveyor Central
- Primary DI
- 00817655022147
- Version / Model
- SCNODE-DAA-BXXEX
- Company Name
- MORTARA INSTRUMENT, INC.
- Labeler DUNS
- 062046149
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-25
- Public Version
- 6
- Public Version Date
- 2023-03-09
- Public Version Status
- Update
- Public Device Record Key
- 16a145d0-2104-49d3-a045-54a6c303661d
- Distribution End Date
- 2023-03-08
Device Description
Patient Monitoring Central Station
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
- No
- 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 |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 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 | 00817655022147 | GS1 |
Customer Contacts
- Phone
- 888-667-8272
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity