Novii

GUDID 35060433670061

Novii Pod

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor

• Primary Device ID: 35060433670061
• NIH Device Record Key: d6db1f78-eb9c-4978-8138-02957a59a8b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novii
• Version Model Number: 107-PT-003
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 877-320-5174
• Email: info@monicahealthcare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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	05060433670060 [Primary]
GS1	15060433670067 [Package]; Contains: 05060433670060; Package: Carton [1 Units]; In Commercial Distribution
GS1	25060433670064 [Package]; Contains: 05060433670060; Package: Carton [2 Units]; In Commercial Distribution
GS1	35060433670061 [Package]; Contains: 05060433670060; Package: Carton [3 Units]; In Commercial Distribution

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: 3
• 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