PeriCALM® Patterns™
GUDID B087PATT02021
PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at
PERIGEN SOLUTIONS LTD
Obstetrical monitoring/analysis software| Primary Device ID | B087PATT02021 |
| NIH Device Record Key | 791182d8-ecc3-48b6-b27e-a1c08fd5f515 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PeriCALM® Patterns™ |
| Version Model Number | 02.02.10 |
| 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 | 8888665339 |
| support@perigen.com | |
| Phone | 8888665339 |
| support@perigen.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B087PATT02021 [Primary] |
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 | 4 |
| Public Version Date | 2018-12-24 |
| Device Publish Date | 2016-05-30 |
On-Brand Devices [PeriCALM® Patterns™]
| B087PATTERNS02081 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making d |
| B087PATT02061 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making d |
| B087PATT02041 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making d |
| B087PATT02021 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making d |
Trademark Results [PeriCALM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERICALM 77801571 3871328 Live/Registered |
PeriGen, Inc. 2009-08-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.