LD-Oxy

GUDID B322D0011

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmograp

LD TECHNOLOGY, LLC

Pulse oximeter, line-powered Pulse oximeter, line-powered

• Primary Device ID: B322D0011
• NIH Device Record Key: 23728be5-d86c-4cc4-8ac7-30d3404a503e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LD-Oxy
• Version Model Number: D001
• Company DUNS: 079443785
• Company Name: LD TECHNOLOGY, LLC
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 305-379-9900
• Email: albert.ldteck@gmail.com
• Phone: 305-379-9900
• Email: albert.ldteck@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B322D0011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160956

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2019-02-18
• Device Publish Date: 2019-01-16

Devices Manufactured by LD TECHNOLOGY, LLC

• B322E0011 - BP-BT Lifeprobes Kiosk: 2024-03-13 "BP-BT Kiosk is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumfer
• B322F0011 - ES-BC: 2024-03-13 EC-BC indication for use: Claculation and historical tracking of : Actual resistance, actual reactance, actual impedance, actual
• B322G0011 - ANS1 Software: 2024-03-13 "ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with data
• B322H0011 - LD-EKG: 2024-03-13 "LD EKG is intended for use: The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical acti
• B322B0011 - TM-Oxi System: 2019-11-08 The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying fun
• B322C0011 - TBL-ABI: 2019-11-08 The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is
• B322A0011 - SweatC: 2019-06-07 SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
• B322D0011 - LD-Oxy: 2019-02-18To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmograp
• B322D0011 - LD-Oxy: 2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel