| Primary Device ID | B322E0011 |
| NIH Device Record Key | 5ead98b7-a489-4171-bbca-e59ea61e91a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BP-BT Lifeprobes Kiosk |
| Version Model Number | E001 |
| 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 | B322E0011 [Primary] |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| 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 circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication : Prescription use in medical or clinic environment only. Rx only." |
| 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 | 2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel |