Novii

Basic Information

• Brand Name: Novii
• Primary DI: 05060433670053
• Version / Model: 107-PT-001
• Company Name: MONICA HEALTHCARE LIMITED
• Labeler DUNS: 346332666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-09-25
• Public Version Status: Update
• Public Device Record Key: 0b662774-c719-4a46-a49a-aa430b8755ac

Device Description

Novii Interface

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	884.2720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43958	Foetal cardiac monitor	A mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by: 1) electronically registering and graphically presenting foetal heart sounds; 2) discriminating foetal and maternal electrocardiographic signals obtained from the maternal abdomen with external electrodes; or 3) transmitting and receiving ultrasonic energy into and from the pregnant woman usually by means of continuous wave (Doppler) echoscopy. The device may include an alarm that signals when the heart rate crosses a pre-set threshold.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060433670050	GS1	Box	1	In Commercial Distribution
Primary	05060433670053	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius