TM-Oxi System

GUDID B322B0011

The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying functional indicated for use in non-invasively oxygen saturation of arterial hemoglobin (SpO2 ), measuring and displaying functional oxygen pulse rate (PR), Non-invasive measurement of saturation of arterial hemoglobin blood pressure (NIBP) of adult patients in (SpO2 ), pulse rate (PR), Non-invasive medical facilities, measurement of blood pressure (NIBP) of TheTM-Oxi device is intended for spot-checking adult and pediatric patients in hospitals, of patients. medical facilities, and sub-acute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients.

LD TECHNOLOGY, LLC

Manual-inflation electronic sphygmomanometer, non-portable
Primary Device IDB322B0011
NIH Device Record Keyc3d26ae8-c4a8-4028-9a53-5660e13d790c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM-Oxi System
Version Model NumberB001
Company DUNS079443785
Company NameLD TECHNOLOGY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB322B0011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-01-16

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 Software2024-03-13 "ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with data
B322H0011 - LD-EKG2024-03-13 "LD EKG is intended for use: The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical acti
B322B0011 - TM-Oxi System2019-11-08The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying functional indicated for use in non-invasively oxygen saturation of arterial hemoglobin (SpO2 ), measuring and displaying functional oxygen pulse rate (PR), Non-invasive measurement of saturation of arterial hemoglobin blood pressure (NIBP) of adult patients in (SpO2 ), pulse rate (PR), Non-invasive medical facilities, measurement of blood pressure (NIBP) of TheTM-Oxi device is intended for spot-checking adult and pediatric patients in hospitals, of patients. medical facilities, and sub-acute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients.
B322B0011 - TM-Oxi System2019-11-08 The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying fun
B322C0011 - TBL-ABI2019-11-08 The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is
B322A0011 - SweatC2019-06-07 SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
B322D0011 - LD-Oxy2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel
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