Duns Number:533337713
Device Description: PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor pr 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.
Catalog Number
-
Brand Name
PeriWatch™ Vigilance™ Curve™
Version/Model Number
02.10.xx
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052715
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
685395ec-345c-4bb2-8343-f0da134a3c5d
Public Version Date
November 25, 2019
Public Version Number
3
DI Record Publish Date
November 12, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |