FaceLake

GUDID 00851908007062

The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.

LORTE TECHNOLOGIES, INC

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00851908007062
• NIH Device Record Key: 9399b725-9011-433d-b0c5-4ecf05a34866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FaceLake
• Version Model Number: CMS-50EW with Bluetooth
• 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@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org
• Phone: 1-847-234-0754
• Email: info@pulseoximeter.org

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851908007062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141362

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-27

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