FM830-SL ENCORE COMPLETE SYSTEM

FM830
DOPPLEX - FM830-SL-ENCORE

Device Description

An 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.

Environmental Conditions

Handling Environment Atmospheric Pressure - millibar

1060.00
680.00

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
10.00

Handling Environment Temperature - Degrees Celsius

35.00
10.00

Storage Environment Atmospheric Pressure - millibar

1060.00
680.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

50.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: HGM

Device Name: System, Monitoring, Perinatal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.2740

Third Party Flag: Y

Medical Specialty: OB

Device Identifiers

Device Id: 05051968031792

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A