Novii

GUDID 05060433670015

Novii Wireless Patch System (GEHC)

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor

• Primary Device ID: 05060433670015
• NIH Device Record Key: cb1904b8-1a0e-461c-9f88-152007c3a900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novii
• Version Model Number: 107-PT-020
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441159496960
• Email: novii.info@ge.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060433670015 [Primary]

FDA Product Code

• OSP: Uterine Electromyographic Monitor

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: 2018-09-25
• Device Publish Date: 2016-09-12

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