SONICAID SF1-SL

GUDID 05051968032133

SONICAID FREEDOM WMTS

HUNTLEIGH HEALTHCARE LIMITED

Cardiotocography telemetric monitoring system

• Primary Device ID: 05051968032133
• NIH Device Record Key: 343e0e79-ad2c-4708-9c66-602359328f35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICAID
• Version Model Number: SF1-SL
• Catalog Number: SF1-SL
• Company DUNS: 217207083
• Company Name: HUNTLEIGH HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Customer Support Contacts

• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051968032133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132650

FDA Product Code

• HGM: System, Monitoring, Perinatal

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: 2019-05-03
• Device Publish Date: 2019-04-25

On-Brand Devices [SONICAID]

• 05051968032713: ELASTIC BELT (LATEX FREE)PAIR
• 05051968032140: 1.5Mhz ULTRASOUND TRANSDUCER 3MTR
• 05051968029843: SONCD FM800 ENCOR EXT U/S TDR-2M
• 05051968029836: SONCD FM800 ENCOR EXT TOCO TDR-3M
• 05051968029829: SONCD FM800 ENCOR EXT TOCO TDR-2M
• 05051968008237: 1.5Mhz ULTRASOUND TRANSDUCER
• 05051968032416: FREEDOM TOCO TDR
• 05051968032409: FREEDOM US TDR (WMTS)
• 05051968032133: SONICAID FREEDOM WMTS
• 05051968041418: USA DIG DOPPLER-FIXED 3MHZ PROBE
• 05051968041401: USA DIG DOPPLER-FIXED 2MHZ PROBE
• 05051968041395: USA DIG DOPPLER-ALKALINE-NO PROBE
• 05051968044037: TEAM3 ANTEPARTUM/ECTG+NIBP+BATTERY USA
• 05051968044020: TEAM3 ANTEPARTUM/ECTG+NIBP USA
• 05051968032522: TEAM3 ANTEPARTUM/PRINTER+NIBP USA
• 05051968032515: TEAM3 ANTEPARTUM/ECTG+BATTERY USA
• 05051968032508: TEAM3 ANTEPARTUM/ECTG USA
• 05051968032492: TEAM3 ANTEPARTUM/PRINTER+BATTERY USA
• 05051968032485: TEAM3 ANTEPARTUM/PRINTER USA
• 00505196832539: TEAM3 ANTEPARTUM/PRINTER+NIBP+BATTERY USA
• 05051968032539: TEAM3 ANTEPARTUM/PRINTER+NIBP+BATTERY USA
• 05051968044310: TEAM3 ANTEPARTUM/PRINTER+NIBP+BATTERY USA
• 05051968044303: TEAM3 ANTEPARTUM/PRINTER+NIBP USA
• 05051968044297: TEAM3 ANTEPARTUM/ECTG+NIBP+BATTERY USA
• 05051968044280: TEAM3 ANTEPARTUM/ECTG+NIBP USA
• 05051968044273: TEAM3 ANTEPARTUM/ECTG+BATTERY USA
• 05051968044266: TEAM3 ANTEPARTUM/ECTG USA
• 05051968044259: TEAM3 ANTEPARTUM/PRINTER+BATTERY USA
• 05051968044242: TEAM3 ANTEPARTUM/PRINTER USA