Novii

GUDID 00840682142700

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor

• Primary Device ID: 00840682142700
• NIH Device Record Key: 9eeef5ae-2bd0-4c6b-990e-2f1377ec5005
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novii
• Version Model Number: Interface 107-PT-001
• Company DUNS: 346332666
• Company Name: MONICA HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682142700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140862

FDA Product Code

• HGM: SYSTEM, MONITORING, PERINATAL
• OSP: Uterine electromyographic monitor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-01
• Device Publish Date: 2019-01-29

On-Brand Devices [Novii]

• 15060433670241: Novii Interface Power Supply
• 35060433670061: Novii Pod
• 15060433670050: Novii Interface
• 05060433670015: Novii Wireless Patch System (GEHC)
• 35060433670078: Novii Patch
• 00840682142731: POD 107-PT-003
• 00840682142700: Interface 107-PT-001