PeriCALM® Patterns™

GUDID B087PATTERNS02081

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 Obstetrical monitoring/analysis software

• Primary Device ID: B087PATTERNS02081
• NIH Device Record Key: 750d0199-3b74-4aeb-9375-0706d4757d38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriCALM® Patterns™
• 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	B087PATTERNS02081 [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: 2017-12-18

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