Novii

GUDID 00840682142700

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor 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