HeraBEAT PACHBT000US

GUDID 17290111520126

HeraBEAT US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate “crosstalk” in the FHR display.

HERA MED LTD

Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system

• Primary Device ID: 17290111520126
• NIH Device Record Key: af509093-0aa8-4945-b4fb-b1a20cf6c09a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeraBEAT
• Version Model Number: HeraBEAT US
• Catalog Number: PACHBT000US
• Company DUNS: 600058601
• Company Name: HERA MED LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290111520129 [Primary]
GS1	17290111520126 [Package]; Contains: 07290111520129; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191110

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20