FDA UDI
In Commercial Distribution
🇺🇸 United States
PeriWatch™ Vigilance™ HUB™
DI: B087HUB01031
·
Model: 01.03.xx
·
PERIGEN SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PeriWatch™ Vigilance™ HUB™
- Primary DI
- B087HUB01031
- Version / Model
- 01.03.xx
- Company Name
- PERIGEN SOLUTIONS LTD
- Labeler DUNS
- 533337713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-12
- Public Version
- 3
- Public Version Date
- 2019-11-25
- Public Version Status
- Update
- Public Device Record Key
- bcb00777-9dca-4aa5-932d-4d8a6a93ae1d
Device Description
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61956 | Obstetrical monitoring/analysis software | A software program intended to facilitate clinical management of pregnancy and/or labour by providing functionality in one or more of the following areas: data acquisition, recording, analysis, and reporting. It typically processes maternal and/or foetal physiologic parameters [e.g., maternal heart rate (MHR) and foetal heart rate (FHR), maternal oxygen saturation (SpO2) and temperature, intrapartum foetal oxygen saturation (FSpO2), intrauterine/amniotic pressure], and is intended to be used in conjunction with specialized monitors in the maternity unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B087HUB01031 | HIBCC |
Customer Contacts
- Phone
- 8552364353
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980719 | 000 |