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Meridian M110 Fetal Monitoring System

Primary DI
00867696000307
Brand
Meridian M110 Fetal Monitoring System
Company
MINDCHILD MEDICAL
Model
M110
Device description
The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MERIDIAN M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals.
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867696000314PackageGS11In Commercial Distribution
00867696000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867696000314008676960003148676960003140867696000314
00867696000307008676960003078676960003070867696000307

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.

Regulatory Flags#

DUNS number
020091217
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867696000321Meridian Disposable fECG Electrode PatchMDPA12017-06-06
00867696000314Meridian M110 Fetal Monitoring SystemM1102017-06-06
00867696000345Meridian Disposable fECG Electrode PatchMDPA12017-06-06
00867696000352Meridian Cable SetMCC012017-06-06

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