FDA.reportPublic FDA data

Monica

Primary DI
15060433670104
Brand
Monica
Company
MONICA HEALTHCARE LIMITED
Model
105-PT-103
Device description
Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
15060433670104PackageGS11In Commercial Distribution
05060433670107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506043367010415060433670104
05060433670107050604336701075060433670107

GMDN Terms#

Term, Definition table
TermDefinition
Foetal cardiac monitorA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
346332666
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060433670053Novii107-PT-0012016-09-12
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
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
05060433670053NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
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
15060433670111MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670135MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670241NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12