Duns Number:533337713
Device Description: PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision- PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
Catalog Number
-
Brand Name
PeriWatch Vigilance® Cues™
Version/Model Number
21.01.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
-
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
1393693a-1a8d-4067-88d4-e891fe8ff7fa
Public Version Date
July 29, 2021
Public Version Number
1
DI Record Publish Date
July 21, 2021
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 |