Novii

GUDID 35060433670078

Novii Patch

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor Foetal cardiac monitor

• Primary Device ID: 35060433670078
• NIH Device Record Key: 7389174f-b800-4197-8d98-b2007d406e8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novii
• Version Model Number: 107-PT-004
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +441159496960
• Email: novii.info@ge.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060433670074 [Primary]
GS1	25060433670071 [Package]; Contains: 15060433670074; Package: Box [10 Units]; In Commercial Distribution
GS1	35060433670078 [Package]; Contains: 25060433670071; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

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