| Primary Device ID | B322F0011 |
| NIH Device Record Key | 966c9d3a-5d89-41fc-80ce-5d6224e3dd3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ES-BC |
| Version Model Number | F001 |
| 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 |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com | |
| Phone | 305-379-9900 |
| albert.ldteck@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B322F0011 [Primary] |
| MNW | Analyzer, Body Composition |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-13 |
| Device Publish Date | 2024-03-05 |
| 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 | 2024-03-13EC-BC indication for use: Claculation and historical tracking of : Actual resistance, actual reactance, actual impedance, actual phase angle,estimated body fat mass, estimated body water,estimated intra-cellular water, estimated extra-cellular water,estimate basic metabolic rate,estimated daily energy expenditure,actual body fat mass |
| 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 | 2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel |