FDA UDI
In Commercial Distribution
🇺🇸 United States
PeriWatch Tracings
DI: 00862095000415
·
Model: 2017 Rev 2.0
·
PERIGEN INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PeriWatch Tracings
- Primary DI
- 00862095000415
- Version / Model
- 2017 Rev 2.0
- Company Name
- PERIGEN INC.
- Labeler DUNS
- 080813890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-11
- Public Version
- 1
- Public Version Date
- 2019-06-19
- Public Version Status
- New
- Public Device Record Key
- 72dcf9d9-d65e-49f6-8b4f-69192cfd2092
Device Description
PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
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
- 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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44104 | Obstetrics information system application software | An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of obstetrical services and facilities. It is typically supplied for installation into a dedicated obstetrics information system or existing mainframe or decentralized computers/networks and is used in a labour ward/maternity unit and allows the electronic entry of a patient’s details of labour for viewing at different locations. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862095000415 | GS1 |
Customer Contacts
- Phone
- 855-236-4353
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080226 | 000 |