PeriCALM® Curve™

GUDID B087CURVE02081

PeriCALM 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: B087CURVE02081
• NIH Device Record Key: 1d179998-4f75-4cec-a15c-2f06fae73ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriCALM® Curve™
• Version Model Number: 02.08.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
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B087CURVE02081 [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: 5
• Public Version Date: 2019-11-25
• Device Publish Date: 2017-12-18

On-Brand Devices [PeriCALM® Curve™]

• 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