FDA.reportPublic FDA data

Novii

Primary DI
05060433670053
Brand
Novii
Company
MONICA HEALTHCARE LIMITED
Model
107-PT-001
Device description
Novii Interface
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSPUterine Electromyographic Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSPUterine Electromyographic MonitorObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060433670050PackageGS11Not in Commercial Distribution
05060433670053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506043367005015060433670050
05060433670053050604336700535060433670053

GMDN Terms#

Term, Definition table
TermDefinition
Foetal/maternal prenatal monitorAn electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 877-320-5174info@monicahealthcare.com

Regulatory Flags#

DUNS number
346332666
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060433670060Novii107-PT-0032016-09-12
05060433670107Monica105-PT-1032016-09-12
05060433670244Novii107-PT-002-US2016-09-12
05060433670015Novii107-PT-0202016-09-12
35060433670078Novii107-PT-0042016-09-12
15060433670050Novii107-PT-0012016-09-12
35060433670061Novii107-PT-0032016-09-12
15060433670098Monica105-PT-1022016-09-12
15060433670104Monica105-PT-1032016-09-12
15060433670111Monica105-PT-1042016-09-12
15060433670135Monica105-PT-1062016-09-12
15060433670241Novii107-PT-002-US2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682142700NoviiDatex-Ohmeda, Inc.OSP2019-01-29
00840682142731NoviiDatex-Ohmeda, Inc.OSP2019-01-29
07290016406030EmbraceTM Electrodes Array (L)O.B - TOOLS LTDOSP2017-02-12
07290016406016TrueLabor Maternal UnitO.B - TOOLS LTDOSP2016-09-21
07290016406023TrueLabor Monitor AdapterO.B - TOOLS LTDOSP2016-09-21
05060433670060NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670107MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670244NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670091NOVII INTERFACE CABLEDatex-Ohmeda, Inc.OSP2016-09-12
05060433670114NOVII INTERFACE CABLEDatex-Ohmeda, Inc.OSP2016-09-12
05060433670138NOVII INTERFACE CABLEDatex-Ohmeda, Inc.OSP2016-09-12
05060433670015NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670050NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
35060433670061NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670098MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670104MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670111MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670135MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670241NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12