FaceLake

GUDID 00851908007161

The FD-300B is a ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.

LORTE TECHNOLOGIES, INC

Foetal Doppler system

• Primary Device ID: 00851908007161
• NIH Device Record Key: 9f359dca-b765-485a-bae5-89801bd5d6f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FaceLake
• Version Model Number: FD-300B
• Company DUNS: 029578633
• Company Name: LORTE TECHNOLOGIES, INC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-847-234-0754
• Email: info@fetaldoppler.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851908007161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082480

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-21

On-Brand Devices [FaceLake]

• 00851908007161: The FD-300B is a ultrasonic Doppler that allows expectant mothers and health care professionals
• 00851908007130: The FD-300P is a ultrasonic Doppler that allows expectant mothers and health care professionals
• 00851908007123: The Facelake FL-420 finger pulse oximeter is a lightweight, portable device used for measuring b
• 00851908007116: The FD-200P is a ultrasonic Doppler that allows expectant mothers and health care professionals
• 00851908007109: The FD-200B is a ultrasonic Doppler that allows expectant mothers and health care professionals
• 00851908007093: JPD-100B Ultrasonic Doppler Fetal Heartbeat Detector is an equipment to detect the fetal heartbe
• 00851908007086: Used for spot-checking blood oxygen saturation levels and pulse rate.
• 00851908007079: The CMS-50F is a wrist pulse oximeter designed to help monitor blood oxygen levels and heart rat
• 00851908007062: The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturati
• 00851908007055: Handheld pulse oximeter used to monitor blood oxygen levels and heart rate
• 00851908007048: The Sonoline B Fetal Doppler is a ultrasonic Doppler that allows expectant mothers and health ca
• 00851908007031: The 50E is a rechargeable pulse oximeter designed to accurately measure oxygen saturation (SpO2)
• 00851908007024: The CMS-50D Plus finger pulse oximeter is a lightweight, portable device used for measuring both
• 00851908007017: The Facelake FL-400 finger pulse oximeter is a lightweight, portable device used for measuring b
• 00851908007000: The Facelake FL-350 finger pulse oximeter is a lightweight, portable device used for measuring b
• 00851908007222: This thermometer can measure body's temperature