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Meridian M110 Fetal Monitoring System

Primary DI
00867696000314
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
OTC
false
Sterile
false
Single use
false

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
CardiotocographA mains electricity (AC-powered) patient monitor that displays the relationship between maternal labour and the foetal heart rate by means of combining and coordinating uterine contraction and foetal heart monitoring during the perinatal period. The uterine contractions are usually recorded using a tocodynamometer (a pressure transducer) which is strapped onto the mother's abdomen. Commonly known as a tococardiograph or a cardiotocograph (CTG) machine, the heart rate is typically measured with a dedicated ultrasound transducer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020091217
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00867696000307Meridian M110 Fetal Monitoring SystemM1102017-06-06
00867696000321Meridian Disposable fECG Electrode PatchMDPA12017-06-06
00867696000345Meridian Disposable fECG Electrode PatchMDPA12017-06-06
00867696000352Meridian Cable SetMCC012017-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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