Novii

GUDID 35060433670061

Novii Pod

MONICA HEALTHCARE LIMITED

Foetal cardiac monitor
Primary Device ID35060433670061
NIH Device Record Keyd6db1f78-eb9c-4978-8138-02957a59a8b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovii
Version Model Number107-PT-003
Company DUNS346332666
Company NameMONICA HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 877-320-5174
Emailinfo@monicahealthcare.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060433670060 [Primary]
GS115060433670067 [Package]
Contains: 05060433670060
Package: Carton [1 Units]
In Commercial Distribution
GS125060433670064 [Package]
Contains: 05060433670060
Package: Carton [2 Units]
In Commercial Distribution
GS135060433670061 [Package]
Contains: 05060433670060
Package: Carton [3 Units]
In Commercial Distribution

FDA Product Code

OSPUterine Electromyographic Monitor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-25
Device Publish Date2016-09-12

On-Brand Devices [Novii]

15060433670241Novii Interface Power Supply
35060433670061Novii Pod
15060433670050Novii Interface
05060433670015Novii Wireless Patch System (GEHC)
35060433670078Novii Patch
00840682142731POD 107-PT-003
00840682142700Interface 107-PT-001

Trademark Results [Novii]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVII
NOVII
98150258 not registered Live/Pending
Rolnitzky, Shimon
2023-08-25
NOVII
NOVII
88552642 not registered Live/Pending
Meng Xianghu
2019-07-31
NOVII
NOVII
79156457 4861475 Live/Registered
Monica Healthcare Limited
2014-07-01
NOVII
NOVII
78136366 2851885 Dead/Cancelled
Novii Technology Solutions, Inc.
2002-06-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.