PeriWatch® Curve™
GUDID B087PWCURV02101
PeriWatch 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.
PERIGEN SOLUTIONS LTD
Obstetrical monitoring/analysis software| Primary Device ID | B087PWCURV02101 |
| NIH Device Record Key | 408d6245-61fd-4a1e-aede-3112e674922b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PeriWatch® Curve™ |
| Version Model Number | 02.10.xx |
| Company DUNS | 533337713 |
| Company Name | PERIGEN SOLUTIONS LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8663216788 |
| support@perigen.com | |
| Phone | 8663216788 |
| support@perigen.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B087PWCURV02101 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052715
FDA Product Code
| HGM | System, Monitoring, Perinatal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2019-03-06 |
Devices Manufactured by PERIGEN SOLUTIONS LTD
| B087CURV202421 - PeriWatch Vigilance® Curve™ | 2024-10-16 PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presenta |
| B087HUB202421 - PeriWatch Vigilance® HUB™ | 2024-10-16 PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote |
| B087PATT202421 - PeriWatch Vigilance® Cues™ | 2024-10-16 PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartu |
| B087CURV202411 - PeriWatch Vigilance® Curve™ | 2024-04-25 PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presenta |
| B087HUB202411 - PeriWatch Vigilance® HUB™ | 2024-04-25 PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote |
| B087PATT202411 - PeriWatch Vigilance® Cues™ | 2024-04-25 PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartu |
| B087CURV202221 - PeriWatch Vigilance® Curve™ | 2024-01-04 PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presenta |
| B087HUB202221 - PeriWatch Vigilance® HUB™ | 2024-01-04 PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote |
Trademark Results [PeriWatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERIWATCH 87307470 5408773 Live/Registered |
PeriGen, Inc. 2017-01-19 |
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