Primary Device ID | B087CURV02061 |
NIH Device Record Key | a3d6e414-a64a-4bc6-b8d5-14b946ccc283 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PeriCALM® Curve™ |
Version Model Number | 02.06.00 |
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 |
Phone | 8888665339 |
support@perigen.com | |
Phone | 8888665339 |
support@perigen.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B087CURV02061 [Primary] |
HGM | System, Monitoring, Perinatal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-11-25 |
Device Publish Date | 2016-05-30 |
B087CURVE02081 | PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singlet |
B087CURV02061 | PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singlet |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PERICALM 77801571 3871328 Live/Registered |
PeriGen, Inc. 2009-08-11 |