FDA UDI
In Commercial Distribution
🇺🇸 United States
PeriWatch Vigilance® Curve™
DI: B087CURV02121
·
Model: 02.12.xx
·
PERIGEN SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PeriWatch Vigilance® Curve™
- Primary DI
- B087CURV02121
- Version / Model
- 02.12.xx
- Company Name
- PERIGEN SOLUTIONS LTD
- Labeler DUNS
- 533337713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-11
- Public Version
- 1
- Public Version Date
- 2020-08-19
- Public Version Status
- New
- Public Device Record Key
- e2f44845-fe8a-4dc9-a063-d122f3b8fe9f
Device Description
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
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 | B087CURV02121 | HIBCC |
Customer Contacts
- Phone
- 8663216788
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052715 | 000 |