FDA UDI
In Commercial Distribution
🇺🇸 United States
CommonPath Enterprise
DI: 00860006582005
·
Critical Alert
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CommonPath Enterprise
- Primary DI
- 00860006582005
- Company Name
- Critical Alert
- Labeler DUNS
- 112008769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- da4c4ad7-b185-475b-b5ea-bbac85e9be48
Device Description
Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | 870.2300 | 2 |
| PHC | Infusion Safety Management Software | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40573 | Alarm application software | An individual software application program or group of programs, routines or algorithms designed for use in, or together with, an alarm device to enable it to function according to its intended purpose. The basic set of applications programs and routines can be upgraded to correct programming errors or to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006582005 | GS1 |